Participate in Research

Are you a healthy woman between the ages of 18-45?

Do you currently have the birth control implant (Nexplanon®) and have had it for the last 1 to 3 years?

Are you interested in participating in a research study to better understand how genetic differences affect how well contraceptives work?

Study Involvement

• The study visit takes approximately 30 minutes.
• You will complete a brief questionnaire and blood will be drawn.
• Compensation will be provided.

Questions? Please contact Delaney Bacon at 303-724-5284 or by email Delaney.bacon@cuanschutz.edu for more information.

Principal Investigator: Aaron Lazorwitz, MD
LINK:  https://clinicaltrials.gov/ct2/show/NCT03092037?term=16-2462&draw=2&rank=1
COMIRB #: 16-2462; Version 2.0

Volunteers needed for exercise research studies!

Researchers at the University of Colorado are conducting clinical trials studying the effects of exercise on diabetes.

Are you interested in the benefits that exercise may be able to offer you?

We are looking for:

• Men or women between 30-55 years old
• Non tobacco users
• Current exercise no more than once per week
• BMI of 25-40
• EITHER type 2 diabetes or no diabetes
• Willing to participate in 4 months of exercise

For more information contact:

The ACTIVE RESEARCH LAB: 303-724-2255 | deirdre.rafferty@ucdenver.edu
Principal Investigator: Jane E.B. Reusch, MD
COMIRB Protocol # 17-0356
LINK: https://clinicaltrials.gov/ct2/show/record/NCT03419195
University of Colorado Denver

LINK TO STUDY PAGE: https://researchstudies.cuanschutz.edu/Search/Study?ProtocolID=4723

Sleep research study at the University of Colorado Boulder, Colorado State University, and Anschutz Medical Campus

Purpose of the Research Study:
This research study is looking at the effect of insufficient sleep on people. Sleeping too little and being awake at the wrong time can impact your ability to think, proteins and hormones in your blood, how your muscle and fat cells work and many other things. This work will be important for people who do not get enough sleep and are at a high risk for developing diabetes and obesity.

Main inclusion/exclusion criteria:

Healthy men and women, ages 18-35

Main procedures involved:

• Blood draws
• Sleep loss
• Tissue biopsies
• Computer testing
• MRI
• Exercise Testing
  

Duration of participation:

7-day laboratory stay

Compensation:

Up to $1,475

Email sleep-study@colostate.edu for study details and ask about the MITO study.

Principal Investigator: Josiane Broussard, PhD
                                                                                                                    LINK TO STUDY PAGE:  https://researchstudies.cuanschutz.edu/Search/Study?ProtocolID=4847

Recently Lost Weight? Want Help Keeping it Off?

Volunteers needed for a research study that will examine the effects of two different diets on weight maintenance.

You may qualify for this study if you:

• Are 21-70 years old
  
• Must have lost more than 10% of your body weight.
  
• Must have completed weight loss in the past 4 weeks.
  
• In good health (no cardiovascular or metabolic disease)
  
• Are not currently taking weight loss medication or appetite-altering medication
  
• Have no history of bariatric or weight-loss specific endoscopic procedure.
  

Participation will include:

• Health and Physical Exam and Questionnaires
  
• Resting Metabolic Rate and Body Composition Exams
  
• Weekly Nutrition Goals and Check-Ins
  

Follow this link to complete a pre-screening survey to see if you may qualify: http://j.mp/2qK6ZAw

In order to enroll, all participants must meet specific criteria. The criteria listed above is only a partial list of requirements to participate in this research study. Only a clinical research staff member can determine eligibility.

If you are interested or have any questions, please contact:

CONTACT: Ashlie Viramontes

EMAIL: Ashlie.Viramontes@ucdenver.edu

Principal Investigator: Tanya Halliday, PhD, RD

LINK TO STUDY PAGE: https://researchstudies.cuanschutz.edu/Search/Study?ProtocolID=5810

Article about MoTrPAC

Eligibility:

• Are 18 years of age or older
  
• Exercise 1 time a week or less
  
• Have no history of diabetes or heart disease
  
• Would like to have an opportunity to exercise with a personal trainer for 12 weeks and have study-related health exams at University of Colorado Anschutz Medical Campus
  

OR

• Are 18 years of age or older
  
• Have been cycling or weight lifting on a regular basis for more than a year
  
• Have no history of diabetes or heart disease
  
• Would like to have the opportunity to participate in human performance testing and have study-related health exams at University of Colorado Anschutz Medical Campus
  

Click here for more information or to volunteer: https://researchstudies.cuanschutz.edu/Search/Study?ProtocolID=10133

Protocol Number: 18-0220
LINK:  https://clinicaltrials.gov/ct2/show/record/NCT03960827

Principal Investigator: Wendy Kohrt, PhD

Study Population
Transgender women from the Denver metropolitan area and/or who utilize health care at University of Colorado Hospital.

Inclusion Criteria:

• Aged 18-40 years old or 50-75 years old
  
• Identify as a transgender woman
  
• Have taken estradiol and spironolactone for at least one year
  
• Currently taking oral or transdermal estradiol
  

Exclusion Criteria:

• Don't identify as a transgender woman
  
• Not currently taking estradiol or spironolactone
  
• Have been on estradiol and spironolactone for less than one year
  
• History of orchiectomy
  
• Current tobacco smoker
  
• Current illicit drug use
  
• History of prior or active estrogen-dependent neoplasms
  
• Acute liver or gallbladder disease
  
• Venous thromobembolism
  
• Hypertriglyceridemia >500 mg/dL
  
• Fasted plasma glucose >7.0 mmol/L or previously treated diabetes
  
• Resting blood pressure >140/90 mmHg

Contact: Sean Iwamoto, MD; 303-724-3662; sean.iwamoto@cuanschutz.edu                                             

Study Link:  https://researchstudies.cuanschutz.edu/Search/Study?ProtocolID=9289

Want to know how your hormones regulate your body fat?

We are looking for:

• Pre-menopausal women: Post-menopausal women:
  
• 18 to 45 years old
  
• No menstrual cycles within the past 6 months
  
• Not currently taking hormonal birth control
  
• Not more than 7 years since last menstrual cycle
  
• Not pregnant or lactating
  

Benefits for study volunteers include:

• Measurement of body composition and bone density
  
• Measurement of resting metabolic rate
  
• Compensation will be provided for your time (up to $925 for post-menopausal women, up to $525 for pre-menopausal women)

If you are interested in participating in the BEAM study:

Please contact the BEAM Study @ 720-848-6399
BEAMstudy@ucdenver.edu

Find out if you qualify now! https://redcap.ucdenver.edu/surveys/
Enter code: PDKY9FYJ4

 

Are you a young woman between 12-21 years old and you have IRREGULAR PERIODS or you have been told that you have PCOS (polycystic ovarian syndrome)?

If you qualify, you will receive at no cost to you:

• 4-months of a medication that can help you lose weight and improve the way your body uses sugar, or 4-months of diet counseling to help you lose weight
  
• Health and physical exam
  
• Measurement of how well your body uses and produces insulin
  
• Body composition testing
  
• MRI imaging of your abdomen and liver
  
• Financial compensation will be provided for qualified participants
  
  

Principal Investigator: Dr. Melanie Cree Green

LINK TO STUDY PAGE: https://researchstudies.cuanschutz.edu/Search/Study?ProtocolID=10028

For more information, call (720) 777-6984
Email: yesenia.garciareyes@childrenscolorado.org

COMIRB # 19-0636

This research study is investigating bone health in adults with type 1 diabetes.

You may qualify if you are:

A postmenopausal woman who is at least 45 years old

OR

A male between 50-90 years of age

Main procedures involved:

• Blood draw and urine sample collection
  
• Bone density scan, CT scan
  
• Questionnaires
  
• Osteoprobe - a procedure which measures fracture toughness (optional)
  
• Duration of participation: 1-2 initial visits with yearly follow-ups for 3 years
  
  

Compensation provided

Contact: Lubna Qamar , 303-724-9925, LUBNA.QAMAR@CUANSCHUTZ.EDU

Principal investigator: Viral Shah, MD

Inclusion Criteria:

• You are between ages of 14 to 22.9 years.
  
• Started etonogestrel implant for the first time and have never used the implant before.
  

Exclusion Criteria:

• There is any contraindication to estrogen containing birth control.
  
• Desire of pregnancy in next 12 months.
  
• Plans to move from the area in next 12 months and is not able to come to the clinic.

Contact: Emily Graves    303-724-3514    EMILY.GRAVES@CUANSCHUTZ.EDU   

Are you interested in participating in a study to understand the health effects of the time we spend sitting?

The ACTIVE Research Lab is looking for:

• Women
• 60 to 75 years of age
  
• Non-smoker
  
• If Type 2 Diabetes, not being treated with insulin
  
• BMI 25-40kg/m2 (check your BMI: https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmicalc.htm)
  

Benefits of participation may include:

• Information regarding your health status and activity levels
• Testing of insulin sensitivity and aerobic fitness
  

For more information, contact:
The ACTIVE Research Lab: (720) 848-6690
Kristina.Chapman@cuanschutz.edu
University of Colorado - Anschutz Medical Campus

Principal Investigator: Mary Whipple, PhD
(COMIRB #19-2758)

https://researchstudies.cuanschutz.edu/Search/Study?ProtocolID=11440

Brief Summary:
This is a Phase I multicenter, open-label, dose-ranging, two-dose PK and PD study of injectable LB at administered as a SQ or IM injection at 40 mg and subsequently at 80 mg SQ or IM depending on the pharmacokinetic and pharmacodynamic results obtained at 40 mg.This study is studying levonorgestrel butanoate (LB) as a possible long-acting and reversible injectable formulation for female contraception.  

Criteria

• Be in good general overall health with no chronic medical conditions that result in periodic exacerbations that require significant medical care.
  
• Between 18 and 40 years inclusive at the enrollment visit.
  
• BMI < 40 kg/m2.
  
• Intact uterus with at least one ovary.
  
• Pap test within ASCCP or ACOG guidelines such that additional treatment will not be required during the study period. If a copy of a Pap test (and indicated follow-up testing) is not available and the subject is 21 years or older, a Pap test should be done during the screening period.
  
• Regular menstrual cycles that occur every 21-35 days:
  
  • If subject is postpartum or post-second trimester abortion, she must have 3 menses (2 cycles) prior to enrollment.
    
  • If subject had a first trimester abortion or pregnancy loss, she must have one spontaneous menses prior to enrollment.
    
• Have a negative urine pregnancy test at the injection visit and no unprotected heterosexual intercourse for the previous 10 days.
  
• Not at risk for pregnancy for the duration of study participation (screening through last phone contact), defined as one of the following:
  
  • heterosexually abstinent;
    
  • previous female permanent contraception procedure;
    
  • in a monogamous relationship with a vasectomized partner;
    
  • consistent use of a non-hormonal barrier method with every act of intercourse (e.g. condoms or diaphragm + spermicide).
    
  • use copper IUD
    
• In the opinion of the investigator, subject is willing and able to comply with the protocol requirements.
  
• Subject is willing to record requested information in the daily diary.
  
• Lives within the study site catchment area or within a reasonable distance from the site.
  
• Understand and sign an IRB approved informed consent form prior to undergoing any screening assessments (including fasting blood draw).
  
• Agree not to participate in any other clinical trials during the course of this study.           

Exclusion Criteria:

• Known hypersensitivity or contraindication to progestins.
  
• Abnormal Transvaginal Ultrasound (TVUS) or safety labs done during the screening period recognized as clinically significant by the investigator (or medically qualified designee).
  
• Greater than 10% body weight change over previous year or planned significant weight loss during the study related to bariatric surgery, dieting or other causes.
  
• Known or suspected current alcohol dependence syndrome, chronic marijuana use or any illicit drug use that may affect metabolism of the study product or study compliance.
  
• Undiagnosed abnormal genital bleeding.
  
• Undiagnosed vaginal discharge, lesions or abnormalities. Subjects diagnosed at screening with BV, trichomonas, candida, Chlamydia or gonococcus infection may be included in the trial following treatment completion. In accordance with PI/medical designee assessment and local standards of practice, women with a history of genital herpes can be included if outbreaks are infrequent. Antiviral prophylactic therapy is permitted.
  
• Uncontrolled thyroid disorder.
  
• Current use of hormonal contraception including hormonal intrauterine device.
  
• Use of a long-acting injectable hormonal contraceptive (e.g., cyclofem or depomedroxyprogesterone acetate) within the past 9 months prior to enrollment unless the subject has had at least one spontaneous menstrual cycle (at least two menses) since the last injection.
  
• Recent use of hormonal oral, patch, intravaginal or intrauterine contraception unless that subject has had at least one complete menstrual cycle (at least two menses) since discontinuation before the treatment injection.
  
• Women who are breastfeeding or are within 30 days of discontinuing breast feeding unless the subject has already had a menses following discontinuation of breastfeeding.
  
• Women planning to undergo major surgery during study participation.
  
• Women planning pregnancy during their anticipated months of study participation.
  
• Women who smoke > 15 cigarettes per day or who use >1 ml/day of nicotine-containing liquid for electronic cigarette must be evaluated by the PI for inclusion based on risk factors that would increase their risk for cardiovascular disease (CVD) and thromboembolism.
  
• Current or past deep vein thrombophlebitis or thromboembolic disorders.
  
• Known history of thrombophilia.
  
• Cerebrovascular or cardiovascular disease or increased risk for arterial thrombosis.
  
• Known or suspected carcinoma of the breast, endometrium, or any other known or suspected progestin-dependent neoplasia.
  
• Current or past medically diagnosed severe depression, which, in the opinion of the investigator, could be exacerbated by use of a hormonal contraceptive, unless she is stable on antidepressant medication.
  
• Have a current need for exogenous hormones or therapeutic anticoagulants.
  
• History of any other carcinoma (excluding basal cell carcinomas) unless in remission for more than 5 years.
  
• Active liver disease or screening LFTs greater than twice the upper limit or normal.
  
• Diastolic blood pressure (DBP) > 95 and Systolic blood pressure (SBP) > 145 mm Hg.
  
• Clinically significant abnormal serum chemistry or hematology values according to the Principal Investigator's judgment.
  
• Participation in another clinical trial involving an investigational drug or device within last the three months before treatment injection or planning to participate in another clinical trial during this study.
  
• A Z-Score of ≤ -2.0 on baseline Dual-energy X-ray absorptiometry (DXA) scan (within 90 days prior to the injection visit).
  
• Known HIV infection.
  
• Women who use any medications on the Exclusionary Medication List (see Appendix 2) OR have used any within 90 days prior to the Injection visit.
  
• Have issues or concerns (in the judgement of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.
  
• Have known hypersensitivity to the active substance LB or any of the excipients of the study treatment.
  
• Use any medications that can interfere with the metabolism of hormonal contraceptives, antibiotics that can interfere with metabolism of hormonal contraceptives, or any drugs designated by the FDA as falling in the Pregnancy and Lactation narrative subsections (formerly Category D or X medications).
  
• Have previously participated in the study. A waiver may be requested to allow subjects to re-enroll, but only in a separate Dosing Group from the prior enrollment(s).
  
• Be a site staff member with delegated study responsibilities or a family member of, or have a close relationship with, a site staff member with delegated study responsibilities.

Contact: Eva Dindinger    303-724-8482    eva.dindinger@ucdenver.edu 

Principal Investigator: Stephanie Teal, MD, MPH; Aaron Lazorwitz, MD, MSCS

 

Eligibility

• Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy aged between 13-45 years (inclusive).
  
• Female subjects at risk of pregnancy aged between 13 and 17 years (inclusive) provided that
  
  • Applicable national, state and local laws allow subjects in this age group to consent/assent to receive contraceptive services,
    
  • All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed.
• Women who
  
  • have never used hormonal contraceptives before consent/assent (naïve users),
    
  • have used hormonal contraceptives in the past, but have had a hormonal contraceptive-free period before consent/assent and a full menstrual cycle during the drug-free period (previous users)
    or
    
  • directly switch from another hormonal contraceptive (switchers).
    
• Only for subjects who were not pregnant and did not use hormonal contraception during the last six months before consent/assent:
• Regular cycles (i.e. cycle length between 24 and 35 days) during the last six months.
  
• Only for women who were pregnant within the last six months before consent/assent: At least three complete menstrual cycles after pregnancy.
  
• At screening, systolic blood pressure '.S 140 mm Hg and diastolic blood pressure '.S 90 mm Hg.
  
• Be able and willing to provide written informed consent/assent prior to undergoing any trial-related procedure.
  
• Willing to use trial contraception for thirteen 28-day cycles.
  
• Be willing to have intercourse in each cycle of the trial without the need to use back-up contraceptive. The use of condoms for prevention of sexually transmittable infections is allowed.
  
• Be willing to state that, to her best knowledge, her male sexual partner/partners has/have not had a vasectomy or been previously diagnosed as infertile.
  
• Agree not to participate in any other clinical trials during the course of this trial (participation in a non-interventional study is allowed).

PI:  Rebecca Cohen, MD, MPH; STEPHANIE TEAL, MD

CONTACT: Noelia Montford
(720) 745-1856
Naila.Naushad@CuAnschutz.edu

Do you or one of your family members have Rheumatoid Arthritis (RA)?

Prevalence of rheumatoid arthritis (RA) is 3x higher in women than in men. The purpose of this study is to learn more about how RA develops in women and why women are differentially affected by this disease.

We are looking for women to take part in this study; participation will include completion of the following activities:

• Study clinic visit (Anschutz Medical Campus)
  
• Questionnaires about your birth control, pregnancy, & other women’s health history
  
• Blood & urine collection
  
• Genital tract sample collection
  
• Joint examination
  
• Possible invitation to additional research visits
  

Who qualifies for this study?

• You are a woman & at least 18 years old
  
• You have been diagnosed with RA OR
  
• You have a parent, sibling, or child with RA
  
• You have had a baby in the last 12 months
  

Compensation Provided:
 In addition to being paid (up to $70 per visit), you will receive
• Free detailed auto-antibody test results
• Free joint exam

Check if you qualify: https://is.gd/FIERAscreen

Contact: Laura Lenis Charry, Research Assistant
Ph: (303)724-0071; Em: LAURA.LENISCHARRY@CUANSCHUTZ.EDU
Location info: Barbara Davis Center (at Anschutz Medical Campus); 1775 Aurora Ct, Aurora, CO 80045

Brief Summary:
This study is being conducted to evaluate the potential therapeutic role of hyperoxia when applied in the immediate ischemic period following a stroke in the controlled Emergency Department setting. The study will evaluate the effects of hyperoxia in stroke patients on the production of markers of free radical damage and inflammatory markers associated with hyperoxic lung injury.                                                                                                                                                                   
Inclusion Criteria:

• Provision of signed and dated informed consent form from patient or legal authorized representative (LAR)
  
• Subject or LAR stated willingness to comply with all study procedures and availability for the duration of the study
  
• Males and females (of unlikely childbearing capacity) aged over 18 years.
  
• Exhibiting signs and physical examination findings suggestive of an acute ischemic infarction
  
  • A target mismatch profile of CT-perfusion or MRI determined by RAPID automated software to have a ratio of PWITmax>6 lesion volume/DWI lesion volume >1.2 and an NIHSS >/=1
    Normoxic; a pulse oximetry of 94% or greater at time of screening without the use of supplemental oxygen
    

Exclusion Criteria:

• Current use of supplemental oxygen
  
• Prisoner
  
• Documented blood glucose <70mg/dL
  
• Concurrent treatment with another investigational drug or other intervention
  
• Documented history of any of the following chronic respiratory illness that require pulmonary vasodilators or supplemental oxygen at baseline: Chronic Obstructive Pulmonary Disorder (COPD), Emphysema, Interstitial Lung Disease, Restrictive Lung Disease, Pulmonary Hypertension
  
• Documented history of any of the following autoimmune diseases: systemic lupus erythematosus, rheumatoid arthritis, scleroderma, primary biliary cholangitis, multiple sclerosis, inflammatory bowel disease
  
• Currently being treated for an acute myocardial infarction and/or decompensated heart failure at the onset of initial ED presentation as reported by the ED provider
  
• Plans for treatment with either IV tPA (alteplase) or endovascular therapy

Contact: Layne Dylla, MD, PhD; 720-848-6777; layne.dylla@cuanschutz.edu

Enrolling by invitation

Are you a woman diagnosed with breast cancer? Do you experience reproductive concerns due to cancer?

Volunteers are needed for a research study exploring the relationship between meaning and psychological distress in young women with breast cancer who experienced reproductive concerns due to cancer diagnosis and treatment and their partners.

You may qualify if you are:

• Female age 18-45 years old
  
• Are within the first two years post-initial diagnosis of breast cancer.
  
• On or considering active treatment which includes current chemotherapy, radiation, surgical planning, and/or hormone therapy interventions.
  
• Experience reproductive concerns due to cancer. This involves concerns about fertility, pregnancy, and parenthood.
  

Participation will include:

Completion of two online or in-person questionnaires over a six-month period (Compensation provided).

You will also have the opportunity to refer your partner to participate in the study.

Note: You are not required to have a partner in order to participate.

If you are interested or have questions, please call research staff Alaina Carr and Sydneyjane Roberts at 720-848-8090 or email at oncpsych@ucdenver.edu.

The criteria mentioned above is only a partial list. If you are interested and believe you might be eligible to participate, please go to this link https://redcap.ucdenver.edu/surveys/?s=P79T3CY7FD.

 

Inclusions

• Female
  
• Diagnosed with breast cancer
  
• Age 18-80 years
  
• Completed surgery
  
• Prescribed an aromatase inhibitor or SERM for at least one year from the time of screening
  

Exclusions:

• Age <18 or >80
  
• Type 1 diabetes
  
• Type 2 diabetes
  
• Prescribed anti-hyperglycemic medication, insulin, or sulfonylurea
  
• Pregnant, breastfeeding, or planning to become pregnant in next 2 months
  
• Have absolute contraindications to exercise testing which are:
  a. Unstable angina
  b. Recent myocardial infarction, cardiac surgery, or vascular surgery (<3 months)
  c. Uncontrolled high blood pressure
  d. Heart failure
  e. Peripheral artery disease (based on report of symptomatic claudication)
  f. Hepatic or renal disease
  g. Severe arthritis or mobility impairment that would interfere with exercise testing
  
  

Contact: Heather Leach, PhD

Questions: Ethan Clark (720) 848-7103; ethan.w.clark@cuanschutz.edu

This is a double-blind, placebo-controlled, crossover study testing whether Vyvanse (lisdexamfetamine; LDX) improves executive functioning (EF) in 100 postmenopausal women who report onset of EF difficulties after oophorectomy. This study involves magnetic resonance imaging (MRI) to see how LDX affects brain chemistry while undergoing two 6-week trials of the study drug and placebo capsules.  UPDATE: We have recently updated this protocol (09/2020) to offer a remote version of the study that can be completed entirely from the participant's home. This alternate version of the study eliminates travel, the MRI, and blood draws.                                                                                                                                     
Inclusion Criteria:

• Female;
  
• Age 35-58;
  
• Have undergone risk-reducing bilateral salpingo-oophorectomy (RRSO) within the previous 15 years AND were premenopausal at the time of RRSO;
  
• Score of ≥ 20 on the Brown Attention Deficit Disorder Scale (BADDS);
  
• Onset of executive function difficulties occurred post RRSO;
  
• Clean urine drug screen (nicotine and marijuana are permissible);
  
• Are fluent in written and spoken English;
  
• Are able to give written informed consent (obtained at screening visit);
  
• Have a high school diploma or equivalent degree (i.e., GED), as per subject report;
  
• If using aromatase inhibitors or tamoxifen: Must have been on a stable dose for at least 6 months;
  
• If completing visits remotely: Must have access to a telecommunications application (i.e., Skype), email, scanner/fax machine, and a private area that enables the protection of participant confidentiality.
  

Exclusion criteria:

• Current, untreated psychiatric disorder;
  
• Substance use disorder within the previous 3 years;
  
• Lifetime history of ADHD or psychotic disorder including bipolar disorder, schizoaffective disorder, and schizophrenia;
  
• Lifetime history of stimulant abuse or dependence;
  
• Regular use of psychotropic medications except selective serotonin reuptake inhibitors (SSRI), serotonin noradrenergic reuptake inhibitors (SNRI), bupropion, zolpidem, gabapentin, or buspirone;
  
• Chemotherapy within the past year;
  
• Previous history of sensitivity or adverse reaction to lisdexamfetamine (LDX);
  
• History of seizures or unstable medical condition;
  
• Known heart disease or clinically significant abnormal electrocardiogram during screening as determined by the study MD;
  
• Uncontrolled hypertension;
  
• Presence of a metallic implant contraindicative to scanning at the 7T level;
  
• Claustrophobia.
  
• Consistent systolic blood pressure of >145mm Hg or diastolic blood pressure >90 mm Hg after three readings at time of screening;
  
• Known renal impairment and End Stage Renal Disease (ESRD).

Contact: Brianna Soreth, MA; 215-573-9695; brianna.soreth@pennmedicine.upenn.edu

Principal Investigator: C. Neill Epperson, MD

Eligibility

• Age 30-55
  
• BMI 25-40
  
• A1C < 5.7% for controls & <9% for those with diabetes
  
• Female participants must be pre-menopausal
  
• Non-tobacco users
  
• Participants with diabetes cannot be taking insulin
  
• Participants cannot have cardiovascular disease or any physical impairment that would limit exercising on a stationary bicycle

Contact: Deirdre Rafferty, MS    720-848-6688    deirdre.rafferty@cuanschutz.edu   
Contact: Kristina Chapman, BS    720-848-6690    kristina.chapman@cuanschutz.edu   
Principal Investigator: Judy Regensteiner, PhD         
Principal Investigator: Jane Reusch, MD         

University of Virginia
Charlottesville, Virginia, United States, 22908
Contact: Lee Hartline, MEd    434-924-5247    lmh9d@virginia.edu   
Contact: Linda Jahn, RN    434-924-1134    las6e@virginia.edu   
Principal Investigator: Zhenqi Liu, MD         

 

The purpose of this research study is to determine the impact of high vs. low iron exposure in exclusively formula-fed infants during the first months of life in high resource settings.  This is a four month-long study, beginning at birth. The first study visit is conducted at the University of Colorado Hospital and the last visit takes place at Children’s Hospital Colorado. The other four visits are conducted in your home.

Formula is provided to all study participants for the duration of the study!

Compensation is also provided.

Main Procedures Involved:

• Collection of stool and blood
• Weight, length, and head circumference measurements
  

Duration of Participation: 4 months   

Principal Investigator
Minghua Tang,  PhD

Contact: Stephanie Gilley, MD, PhD STEPHANIE.GILLEY@CUANSCHUTZ.EDU

Brief Study Description: 

The IPAP Project wants to know if taking part in a group-based interpersonal psychotherapy (IPT) program designed to improve mood and lessen stress in girls with PCOS will improve depression, unhealthy eating behaviors, weight, and insulin resistance.

Brief Study Timeline: 

• Screening/Baseline (2 Hours; $50): Consent/Assent, Surveys, Body Measurements, Fasting Venipuncture Randomized to 1 of 2 Conditions
  
• Usual PCOS Care (i.e., assessment only) 
  
• Usual PCOS Care + Group Based IPT delivered via telehealth (6 x 1 hour weekly sessions)
  
• Immediate Post-Intervention Follow-Up (1-2 Hours; $75); Surveys,
• Body Measurements, Fasting Venipuncture
  
• 6 Month Follow Up (1-2 Hours; $75); Surveys, Body Measurements,
• Fasting Venipuncture                                                                                                 

Inclusion Criteria                                                                                                      

• Diagnosed PCOS duration ≥3 months
• Age 12-17y
  
• At-risk for excess weight gain (BMI ≥75th percentile)
  
• Elevated depression symptoms (CES-D ≥16)                                                                                                                                    

Exclusion Criteria:                                                                                                                                                                                                           

• Weekly or bi-weekly therapy with licensed behavioral health provider
  
• Major medical condition not related to PCOS (e.g., cancer, Prader Willi, developmental disability)
  
• HbA1c ≥7.0%

To take part in this research study or for more information, please call or text: Maggie Kaiser at 970-286-5577 or email ipapstudy@childrenscolorado.org 

Principal Investigator: Lauren Gulley at Colorado State University, University of Colorado Denver, and Children’s Hospital Colorado Co-

Investigator/Mentor:
Melanie Cree-Green, MD, PhD
Melanie.green@childrenscolorado.org;

Co-Investigator/Mentor:
Lauren B. Shomaker, PhD
Lauren.shomaker@childrenscolorado.org; 

Co-Investigator:
Eliza Buyers, MD
Eliza.buyers@childrenscolorado.org

                                                 

This study plans to learn more about how triglyceride levels in pregnancy affect newborn fat mass. Obesity in pregnancy, in the absence of gestational diabetes, is now the most common cause of large-for-gestational-age infants and increased newborn fat mass. Previous data supports the idea that maternal triglycerides, not glucose, are the strongest predictor of both total newborn fat mass and liver fat. In this study, mothers will monitor triglyceride and glucose levels at specific points in pregnancy using point-of-care meters at home. Two weeks after birth, infants will have total fat measured by air-displacement plethysmography (PEAPOD) and liver fat measures by Magnetic Resonance Spectroscopy (MRS). The central hypothesis is that in obesity, fasting triglycerides and postprandial triglycerides will predict newborn fat mass in a free-living environment.                                                                                                                               

Ages Eligible for Study: up to 39 Years   (Child, Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Study Population: Overweight and obese pregnant women between the ages of 20-39 years old, who are receiving care at a University of Colorado Health Facility.

Inclusion Criteria:

• Pregnant women less than 16 weeks gestational age
• Between the ages of 21-39 years
• Pre-pregnancy BMI 28-39 kg/m2
  

Exclusion Criteria:

• Pre-gestational diabetes or prediabetes
• History of gestational diabetes
• History of pre-eclampsia, spontaneous pre-term delivery, or gestational hypertension <34wks
• Tobacco or illicit substance use
• Chronic steroid use

Principal Investigator: Linda A Barbour, MD, MSPH

Principal Investigator: Teri L Hernandez, PhD, RN                      

Contact: Emily Z Dunn, MS,

303-724-0320

Emily.2.Dunn@cuanschutz.edu

Nicole Hirsch, MS           

303-724-0572   

Nicole.Hirsch@cuanschutz.edu

This randomized control trial examines differences in glycemia and insulin sensitivity, acute and 1-month glucose fluctuations and 1-month glucose disposal pathways between two physical activity strategies: BREAK and ONE. The BREAK strategy consists of 5-minute bouts of brisk walking performed hourly for 9 hours/day, 5 days per week, and the ONE strategy consists of a single 45-minute bout of brisk walking 5 days per week. The intervention will be maintained for two more months and glucose control will be tested. Participants will be male and female adult volunteers with overweight or obesity and pre-diabetes, a population that may be seeking physical activity options to control glucose.                                   

Age
Adult

Eligibility

• Male and female
• Overweight and obese BMI of 25-40 kg/m2and weight stable over the previous 6 months.
• Age, 18-45 years old.
• Fasting glucose of 100-125 mg/dL or fasting HbA1c of 5.7-6.4%, or 2h OGTT blood glucose of 140-199mg/dL based on the American Diabetes Association criteria for pre-diabetes.
• Less than 150 minutes of moderate-to-vigorous physical activity (MVPA) per week and more than 6 hours of sitting time per day, as self-reported by the volunteers using the IPAQ.

Inclusion Criteria:

• Male and female
• Overweight and obese BMI of 25-40 kg/m2and weight stable over the previous 6 months.
• Age, 18-45 years old.
• Fasting glucose of 100-125 mg/dL or fasting HbA1c of 5.7-6.4%, or 2h OGTT blood glucose of 140-199mg/dL based on the American Diabetes Association criteria for pre-diabetes.
• Less than 150 minutes of moderate-to-vigorous physical activity (MVPA) per week and more than 6 hours of sitting time per day, as self-reported by the volunteers using the IPAQ.
• Less than 6500 of steps per day as measured by a pedometer over 5 days (at least 1 weekend day).
• Passing medical and physical screening, and analysis of blood and urine screening samples.
• Low-moderate caffeine use (<3 cups/day).
• Agree to refrain from alcohol and caffeine for 72 h before and during the inpatient CTRC visits.
• Agree to refrain from any other structured exercise than the physical activity prescribed in each arm of the study.
• Agree to eat control diets for 3 days before and during the CTRC visits;
• Agree to refrain from taking any over-the-counter (including nonsteroidal anti-inflammatory drugs) or prescribed medication (apart from oral contraceptives) for 3 days prior to the inpatient CTRC visits;
• Agree to wear a Fitbit activity monitor and upload data on the website on a daily basis for the whole duration of the study.
• Agree to follow the physical activity interventions and to be randomly assigned to one of the two arms of the study.
• Agree to complete all the study procedures.
  

Exclusion Criteria:

• Pregnancy, breast-feeding or post-menopause for women.
• Being considered unsafe to participate as determined by the study physician (Dr. Bessesen).
• Ever having a history of systemic, psychiatric, neurological disease, or drug and alcohol abuse.
• History of cardiovascular disease, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases, dyslipidemia or any other medical condition affecting weight or lipid metabolism.
• Being positive for human immunodeficiency virus or hepatitis B or C.
• Taking medications affecting weight, triglycerides, energy intake/energy expenditure, or sleep in the last 3 months.
• Having abnormal blood chemistry and/or hematology as deemed significant by the study physician.
• Having a positive drugs of abuse urine screen at screening or upon entry into the laboratory session.
• Being a smoker or having been a smoker in the 3 months prior to their screening visit.
• Having donated over 400 mL of blood within 3 months (90 days) of screening for the study;
• Working night shifts or traveling across more than 2 time zones within 1 month of and throughout the study.
• Not completing the trial days of BREAK and ONE during the screening period to assess the willingness and ability of the participant to perform each of the interventions.
  

Principal Investigator:

Audrey Bergouignan, PhD         

University of Colorado Anschutz Medical Campus 

Email: ana.pinto@cuanschutz.edu                                                                                                                       

                 

Eligibility
Generally healthy premenopausal (ages 18-55 years) and postmenopausal women (ages 45-55) years of all races/ethnicities will be enrolled.

• Premenopausal women will have regular menstrual periods (every 21-35 days).
• Postmenopausal women will have gone through natural (i.e., non-surgical) menopause with the final menstrual period occurring less than 6 years ago.

Exclusion criteria:

• Medications to treat high blood pressure, cholesterol, diabetes or heart disease
• Use of menopausal therapy or oral contraceptives
• Currently pregnant or intending to become pregnant
• Smoking
  

Principal Investigator: Lyndsey DuBose, PhD

University of Colorado Anschutz Medical Campus

Contact PI: Lyndsey DuBose, PhD       tel: 720-848-5596  lyndsey.dubose@cuanschutz.edu
Contact: Kerrie Moreau, PhD                tel: 303-724-1914 kerrie.moreau@cuanschutz.edu

We are recruiting individuals who experience PTSD-associated nightmares to participate in a research study to help us understand if improving sleep quality, by reducing the impact of nightmares can improve cardiovascular health. We are recruiting volunteers who experience PTSD-related nightmares to participate in a research study. Main procedures include: Sleep monitoring and nightmare intervention, assessment of bone mineral density and body composition, ultrasound of blood vessels, cognitive and psychological assessments, blood draw                                                                                                                                                                                     
Eligibility
1) Experience repetitive nightmares
2) Men and women age 22 years or older
3) No uncontrolled high blood pressure
4) Non-smoking
5) No history of cancer, diabetes, or cardiovascular/heart disease
6) No use of hormone therapy currently or in the last 6 months

Principal Investigator: Kerrie Moreau, PhD 

University of Colorado Anschutz Medical Campus         

Contact: kerrie.moreau@cuanschutz.edu