Ongoing Studies
Active Study - Currently Enrolling
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 orforlipron or insulin glargine.
Principle investigator: Neda Rasouli, MD
COMIRB#:23-0289
Contact
Wyatt Pfau, CRC
303-724-1291
wyatt.pfau@cuanschutz.edu
Active Study - Currently Enrolling
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(s).
Learn more about the study and detailed Inclusion/Exclusion criteria
Principle investigator: Neda Rasouli, MD
COMIRB#:19-2285
Contact
Avinash Pyreddy, Team Lead, CRC
303-724-1293
avinash.pyreddy@ucdenver.edu
Active Study - Currently Enrolling
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
Active Study - Currently Enrolling Chronic Kidney Disease (CKD)
SURMOUNT-MMO: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Tirzepatide on the Reduction of Morbidity and Mortality in Adults with Obesity
Objective: To see how Tirzepatide compares to placebo (no tx) 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. Chance you get placebo.
Principle investigator: Neda Rasouli, MD
COMIRB: 20-0271
Contact
Rachel Nwogo, Clinical Research Coordinator
303-724-1293
rachel.nwogo@ucdenver.edu
Active Study - Enrollment Closed
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
Principle investigator: Neda Rasouli, MD
COMIRB#:23-0754
Contact
Wyatt Pfau, CRC
303-724-1291
wyatt.pfau@cuanschutz.edu
Active Study - Enrollment Closed
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
Avinash Pyreddy, Team Lead, CRC
303-724-1293
avinash.pyreddy@ucdenver.edu
Active Study - Enrollment closed
SURPASS CVOT: The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes
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
Courtney King, Clinical Research Coordinator
303-724-1290
courtney.king@ucdenver.edu
Active Study - Currently Enrolling
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 orforlipron or insulin glargine.
Principle investigator: Neda Rasouli, MD
COMIRB#:23-0289
Contact
Wyatt Pfau, CRC
303-724-1291
wyatt.pfau@cuanschutz.edu
Active Study - Enrollment Closed
FOCUS: Long term effect of semaglutide on diabetic retinopathy in subjects with type 2 diabetes
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.
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
Active Study - Enrollment Closed
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
720-848-6245
vatsala.singh@ucdenver.edu
Active Study - Enrollment Closed
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
720-848-6245
vatsala.singh@ucdenver.edu
Study Complete - Data Analysis | No Longer Enrolling
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
Rebecca Lorch, University Operations Manager & Senior CRC
720-848-1852
rebecca.lorch@cuanschutz.edu
Study Completed
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
Rebecca Lorch, University Operations Manager & Senior CRC
720-848-1852
rebecca.lorch@cuanschutz.edu
Study Completed
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
Carli Berghoff, Clinical Research Coordinator
720-848-1816
carli.berghoff@cuanschutz.edu
Study Completed
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
Carli Berghoff, Clinical Research Coordinator
720-848-1816
carli.berghoff@ucdenver.edu
Future Study - Enrolling Soon
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:
Carli Berghoff, CRC
720-848-1816
carli.berghoff@cuasnchutz.edu
For more information email cudect@ucdenver.edu or call 720-848-7174.
Endocrinology (SOM)
CU Anschutz
Research I South
12801 East 17th Avenue
7103
Aurora, CO 80045
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