Ongoing Studies
ACTIVE STUDIES – CURRENTLY ENROLLING
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REACH: Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness in Diabetes
Objective: This study will test how exercise impacts heart health, blood vessel function, and how the body uses sugar, among adults with and without T2D.
Participation: If you join this study, we will complete testing to see how your heart, blood vessel, and muscles are currently functioning. These tests, called baseline tests, show how well you can exercise. They include riding a stationary bicycle while we measure your oxygen use, doing a scan of your heart and muscles using an ultrasound, checking to see how your body uses sugar, a small muscle sample (biopsy), and an MRI scan. Then, you will do 15 weeks of exercise training after which we will repeat all the tests.
Status: Active, currently enrolling new participants
Principle investigator: Judy Regensteiner, PhD
Contact
Ben Juckett
benjamin.juckett@cuanschutz.edu
RADIANT: Rare and Atypical Diabetes Network
Objective: The Rare and Atypical DIAbetes NeTwork (RADIANT) study is dedicated to characterizing (discovering and defining) rare and atypical forms of diabetes
Participation: Qualified study participants will be followed for approximately 1-3 years. If you qualify, you will undergo rounds of lab work and data collection, but will receive no study medication.
Status: Active, currently enrolling new participants
Learn more about the study and detailed Inclusion/Exclusion criteria
Principle investigator: Neda Rasouli, MD
COMIRB#:19-2285
Contact
Marjan Rezaei, Clinical Research Coordinator
303-724-1290
marjan.rezaei@cuanschutz.edu
ACTIVE STUDIES – ENROLLMENT CLOSED
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ACHIEVE-4
Objective: The Achieve-4 study is designed to analyze if orforglipron is noninferior to insulin glargine in prevention of major adverse cardiovascular events and glycemic control in those with type 2 diabetes mellitus.
Participation: Qualified study participants will attend study visits for approximately 1-2 years. If you qualify, you will undergo rounds of lab work and data collection and will be given either orforglipron or insulin glargine.
Status: Active, closed to enrollment
Principle investigator: Neda Rasouli, MD
COMIRB#:23-0289
Contact
Reena Agarwal, Clinical Research Coordinator
303-724-1291
reenadevi.agarwal@cuanschutz.edu
TRIUMPH OUTCOMES
Objective: The TRIUMPH-Outcomes study is designed to learn if Retatrutide is superior to placebo in reducing the risk of major heart related events and the decline in kidney function for participants with Body mass index (BMI) greater than or equal to 27 Kg/m2.
Participation: Qualified study participants will attend study visits for approximately 3.5- 5 years. If you qualify, you will undergo rounds of lab work and data collection. Participants will be given Retatrutide or placebo.
Status: Active, closed to enrollment
Principle investigator: Neda Rasouli, MD
COMIRB#:24-0101
Contact
Reena Agarwal, Clinical Research Coordinator
303-724-1291
reenadevi.agarwal@cuanschutz.edu
REIMAGINE-4:
Objective: The REIMAGINE-4 study is designed to compare the effect of CagriSema 2.4 mg/2.4 mg versus Tirzepatide 15 mg on glycemic control and weight loss as well as safety and tolerability in people with T2D in inadequate glycemic control on metformin with or without an SGLT2 inhibitor.
Participation: Qualified participants will be followed for visits across 72 weeks. If you qualify you will receive study-related care and either CagriSema or Tirzepatide.
Status: Active, closed to enrollment
Principle investigator: Neda Rasouli, MD
COMIRB: 23-2330
Contact
Mahdiyah Muwwakil, Clinical Research Coordinator
303-724-1293
Mahdiyah.muwwakil@ucdenver.edu
DOSE-FINDING:
Objective: The Dose-Finding study examines the safety, efficacy, pharmacokinetics of 7 dose levels of the medicine NNC0519-0130 and how well the different doses lower blood sugar in people with type 2 diabetes, compared with placebo and active comparator tirzepatide.
Participation: Qualified participants will be followed for visits across 40 weeks. If you qualify you will receive study-related care and study medication at no cost.
Status: Active, closed to enrollment
Principle investigator: Neda Rasouli, MD
COMIRB: 23-2258
Contact
Mahdiyah Muwwakil, Clinical Research Coordinator
303-724-1293
Mahdiyah.muwwakil@ucdenver.edu
ACTIVE STUDIES – ENROLLMENT CLOSED
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ACHIEVE-4
Objective: The Achieve-4 study is designed to analyze if orforglipron is noninferior to insulin glargine in prevention of major adverse cardiovascular events and glycemic control in those with type 2 diabetes mellitus.
Participation: Qualified study participants will attend study visits for approximately 1-2 years. If you qualify, you will undergo rounds of lab work and data collection and will be given either orforglipron or insulin glargine.
Status: Active, closed to enrollment
Principle investigator: Neda Rasouli, MD
COMIRB#:23-0289
Contact
Reena Agarwal, Clinical Research Coordinator
303-724-1291
reenadevi.agarwal@cuanschutz.edu
FOCUS:
Objective: To assess the long-term effects of treatment with semaglutide compared to placebo, both added to standard-of-care, on diabetic retinopathy development and progression in subjects with T2D.
Participation: Qualified study participants will be approximately 5 years. If you qualify, you will receive study-related care and study medication(s) at no charge. You will receive compensation for your participation in the study.
Status: Active, closed to enrollment
Learn more about study and detailed Inclusion/Exclusion criteria
Principle investigator: Neda Rasouli, MD
COMIRB#:19-0480
Contact
Vatsala Singh, VA Operations Manager & Senior CRC
720-848-6245
vatsala.singh@ucdenver.edu
ENROLLMENT CLOSED: DATA ANALYSIS
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Impact of SARS-CoV-2 on Post-hospital Recovery of Carbohydrate and Muscle Metabolism: Role of Endothelial Injury
Objective: To goal of this study is to understand the consequences of COVID-19 infection on carbohydrate metabolism and diabetes complications.
Participation: Qualified study participants will be hospitalized and have confirmed COVID-19 diagnosis and hypoxia requiring dexamethasone treatment. The study duration is 14 weeks.
More information on detailed inclusion/exclusion criteria will be provided in the near future.
Principle investigator: Jane Reusch, MD
COMIRB#:21-3711
Contact:
Vatsala Singh, VA Operations Manager & Senior CRC
720-848-6245
vatsala.singh@ucdenver.edu
ACTIVE STUDIES – ENROLLMENT CLOSED
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ACCLAIM-Lp(a):
Objective The ACCLAIM-Lp(s) study investigates the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults with Elevated Lipoprotein(a)
Participation: Qualified participants will be followed for visits across 5-6 years. If you qualify you will receive study-related care and study medication at no cost.
Status: Active, closed to enrollment
Principle investigator: Neda Rasouli, MD
COMIRB: 24-0197
Contact
Anvay Raje, Clinical Research Coordinator
303-724-1293
anvay.raje@cuanschutz.edu
ACTIVE STUDIES – CURRENTLY ENROLLING
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AMYLYX:
Objective: The AMYLYX study will evaluate the efficacy of avexitide compared to placebo for reduction of Level 2 and Level 3 hypoglycemic events in participants with post bariatric hypoglycemia related to Roux-en-Y gastric bypass (RYGP) who are not adequately controlled on dietary management for reduction of hypoglycemia.
Participation: Qualified participants will be followed for visits across 58 weeks. If you qualify you will receive study-related care and study medication at no cost.
Status: Active, currently enrolling new participants
Principle investigator: Helen Lawler, MD
COMIRB: 25-0052
Contact
Vedashree Bhide, Clinical Research Coordinator
303-724-1293
vedashree.bhide@cuanschutz.edu
MBX:
Objective: The MBX study will assess the preliminary efficacy of single subcutaneous administration of MBX 1416 at 2 dose levels in participants aged between 18 and 65 years with documented PBH.
Participation: Qualified participants will be followed for visits over 40 days. If you qualify you will receive study-related care and study medication at no cost.
Status: Active, currently enrolling new participants
Principle investigator: Helen Lawler, MD
COMIRB: 25-1550
Contact
Anvay Raje, Clinical Research Coordinator
303-724-1293
anvay.raje@cuanschutz.edu
ACTIVE STUDIES – CURRENTLY ENROLLING
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IMVT:
Objective: The IMVT study will assess the efficacy, safety, and tolerability of IMVT-1402 at two dose levels in adult patients with Graves’ Disease who are hyperthyroid despite antithyroid drugs (ATDs) treatment.
Participation: Qualified study participants will attend study visits for 35 weeks, will receive either IMVT-1402 or placebo at no cost.
Status: Active, currently enrolling new participants
Principle investigator: Whitney Goldner, MD
COMIRB: 25-1279
Contact
Marjan Rezaei, Clinical Research Coordinator
303-724-1290
marjan.rezaei@cuanschutz.edu
ACTIVE STUDIES – ENROLLMENT CLOSED
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ATTAIN-1
Objective: The Attain-1 study is designed to analyze if orforglipron is protective against common comorbidities with obesity or overweight.
Participation: Qualified study participants will attend study visits for approximately 1-3 years. If you qualify, you will undergo rounds of lab work and data collection, and will receive either orforglipron or a placebo.
Status: Active, closed to enrollment
Principle investigator: Neda Rasouli, MD
COMIRB#:23-0754
Contact
Reena Agarwal, Clinical Research Coordinator
303-724-1291
reenadevi.agarwal@cuanschutz.edu
SURMOUNT-MMO:
Objective: The Surmount-MMO study is to see how Tirzepatide compares to placebo in preventing cardiovascular events in participants with obesity and a higher risk of major adverse cardiovascular events.
Participation: Qualified participants will be followed for visits across 5-6 years. If you qualify you will receive study-related care and study medication at no cost.
Status: Active, closed to enrollment
Principle investigator: Neda Rasouli, MD
COMIRB: 22-1571
Contact
Sophia Siong, Clinical Research Coordinator
303-724-1293
sophia.siong@cuanschutz.edu
STUDY COMPLETE: DATA ANALYSIS | NO LONGER ENROLLING
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Objective: To compare the relative effectiveness of 4 commonly used glucose-lowering medications when combined with metformin to see which combination is most effective at lowering blood glucose levels.
Participation: Qualified study participants will be followed for 13 scheduled visits over approximately 5 years. If you qualify, you will receive study-related care and study medication(s) at no charge.
Learn more about the study and detailed Inclusion/Exclusion criteria
Principle investigator: Neda Rasouli, MD
COMIRB#:13-0131
Contact
Vatsala Singh, VA Operations Manager & Senior CRC
303-724-1228
vatsala.singh@ucdenver.edu
ELIRA: Safety and effectiveness of Transcutaneous Electrical Nerve simulation (TENS) - Assisted weight loss and/or appetite suppression
Objective: The purpose of this study is to demonstrate safety and effectiveness of wareable patch TENS system in driving weight loss and appetite suppression.
Participation: Qualified study participants will be followed for about 12 weeks. If you qualify, you will receive study-related care and study medication(s) at no charge. You will receive compensation for travel expenses.
Learn more about the study and detailed Inclusion/Exclusion criteria
Principle investigator: Neda Rasouli, MD
COMIRB#:18-1026
Contact
Vatsala Singh, VA Operations Manager & Senior CRC
303-724-1228
vatsala.singh@ucdenver.edu
FLOW: Effect of semaglutide versus placebo on the progression of renal impairment in subjects with type 2 diabetes and chronic kidney disease
Objective: To demonstrate that semaglutide delays the progression of renal impairment and lowers the risk of renal and cardiovascular mortality compared to placebo, both added to standard-of-care, in subjects with type 2 diabetes and chronic kidney disease.
Participation: Qualified study participants will be followed between 3 to 5 years. If you qualify, you will receive study-related care and study medication(s) at no charge. You will receive compensation for your participation in the study.
Learn more about study and detailed Inclusion/Exclusion criteria
Principle investigator: Neda Rasouli, MD
COMIRB#:19-0989
Contact
Vatsala Singh, VA Operations Manager & Senior CRC
303-724-1228
vatsala.singh@ucdenver.edu
SOUL: Semaglutide cardiovascular outcomes trial in patients with type 2 diabetes
Objective: To demonstrate that oral semaglutide lowers the risk of major adverse cardiovascular events (MACE) compared to placebo, both added to standard of care in patients with T2D and at high risk of CV events.
Participation: Qualified study participants will be followed between 3.5 to 5 years. If you qualify, you will receive study-related care and study medication(s) at no charge. You will receive compensation for your participation in the study.
Learn more about study and detailed Inclusion/Exclusion criteria
Principle investigator: Neda Rasouli, MD
COMIRB#:19-0757
Contact
Vatsala Singh, VA Operations Manager & Senior CRC
303-724-1228
vatsala.singh@ucdenver.edu
IDOS: Evaluation of Intestinal Permeability and Chronic Inflammation in Patients with Type 2 Diabetes and Obesity Compared to Healthy Lean Controls
Objective: To learn more about measures of intestinal barrier function and inflammation in obese individuals with type 2 diabetes compared to lean healthy controls.
Participation: Qualified participants will be followed for 2 visits across 1-2 months. If you qualify you will receive study-related care at no cost.
Inclusion criteria: History of T2DM, BMI > 28, use of Metformin, CRP > 1.0.
Exclusion criteria: Regular NSAID use, BMI < 28, CRP < 1.0, steroid use, T2DM medication use beyond Metformin, significant heart failure, probiotic use, inflammatory intestinal diseases.
Principle investigator: Neda Rasouli, MD
COMIRB: 20-2179
Contact
Vatsala Singh, VA Operations Manager & Senior CRC
303-724-1228
vatsala.singh@ucdenver.edu
SURPASS CVOT
Objective: To see how Tirzepatide compares to dulaglutide in preventing cardiovascular (heart and blood vessel) events in participants with type 2 diabetes and a higher risk of cardiovascular events.
Participation: Qualified participants will be followed for visits across 5-6 years. If you qualify you will receive study-related care and study medication(s) at no cost.
Principle investigator: Neda Rasouli, MD
COMIRB: 20-0271
Contact
Vatsala Singh, VA Operations Manager & Senior CRC
303-724-1228
vatsala.singh@ucdenver.edu
Somalogic: Impact of SomaSignal Tests on the choice of glucose-lowering medications: An Adaptive Implementation Study
Objective: The goal of the study is to determine if providing the results of a new test that assesses cardiovascular risk factors to care providers will impact prescriptions or medical management of individuals of type 2 diabetes.
Participation: Qualified participants must be receiving care at UC Health Systems, are age 40 or older, and are diagnosed with type 2 diabetes. The duration of the study is 6 months.
More information about the study and detailed Inclusion/Exclusion criteria will be provided in the near future.
Principle investigator: Neda Rasouli, MD
COMIRB: 21-4510
Contact
Vatsala Singh, VA Operations Manager & Senior CRC
303-724-1228
vatsala.singh@ucdenver.edu
SIB: A Randomized Parallel Comparison of Semaglutide versus Placebo on Intestinal Barrier Function in Type 2 Diabetes Mellitus
Objective: To learn more about the safety and effectiveness of Semaglutide for treating intestinal permeability and chronic inflammation in patients with type 2 diabetes.
Participation: Qualified participants will be followed for visits across 20 weeks. If you qualify you will receive study-related care and study medication(s) at no cost.
Principle investigator: Neda Rasouli, MD
COMIRB: 21-2774
Contact
Marjan Rezaei, Clinical Research Coordinator
303-724-1290
marjan.rezaei@cuanschutz.edu
QWINT-1/BDCW: A Phase 3, Parallel-Design, Open-Label, Randomized Control Study to Evaluate the Efficacy and Safety of LY3209590 Administered Weekly Using a Fixed Dose Escalation Compared to Insulin Glargine in Insulin-Naïve Adults with Type 2 Diabetes
Objective: The QWINT-1 study is dedicated to comparing and evaluating the Efficacy and Safety of Once Weekly insulin compared to daily Insulin Glargine in Insulin-Naïve Adults with Type 2 Diabetes
Participation: Qualified study participants will be followed for approximately 12-15 months. If you qualify, you will undergo rounds of lab work and data collection in addition to either once weekly insulin or Insulin glargine daily.
Principle investigator: Neda Rasouli, MD
COMIRB#:22-1572
Contact
Vatsala Singh, VA Operations Manager & Senior CRC
303-724-1228
vatsala.singh@ucdenver.edu
For more information email cudect@ucdenver.edu or call 303-724-1293.
Endocrinology
CU Anschutz
Research I South
12801 East 17th Avenue
7103
Aurora, CO 80045
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