Treating PCOS With Exenatide vs Active Lifestyle Intervention (TEAL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03919929|
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : September 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|PCOS Adolescent Obesity NAFLD||Drug: Exenatide 2 MG [Bydureon] Other: Weight loss diet||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treating PCOS With Exenatide vs Active Lifestyle Intervention|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||July 2024|
|Estimated Study Completion Date :||July 2024|
Active Comparator: Diet Intervention
Weight loss with dietary intervention
Other: Weight loss diet
Prescribed weight loss diet to match weight loss in Drug arm
Experimental: GLP-1 Intervention
Participants will receive long-acting Exenatide once a week for 12 weeks.
Drug: Exenatide 2 MG [Bydureon]
Exenatide once weekly for 12 weeks
Other Name: GLP-1 receptor agonist
- Change in Hepatic Fat Fraction [ Time Frame: Baseline and 12 weeks ]Change from baseline in presence/severity of hepatic fat fraction will be measured with MRI, and calculated via the Dixon method as the proton density hepatic fat fraction, which ranges from 0-75%.
- Change in Rate of De Novo Lipogenesis [ Time Frame: Baseline and 12 weeks ]Change from baseline of the rate of overnight de novo lipogenesis will be measured utilizing stable isotope methods with deuterated water, and expressed as the rate of newly synthesized lipids in the serum triglyceride fraction.
- Change in Whole Body Insulin Sensitivity [ Time Frame: Baseline and 12 weeks ]Participants will undergo a 75 gram oral glucose tolerance test, and the change from baseline in whole body insulin sensitivity will be expressed as Si, calculated via the oral minimal model.
- Change in Adipose Insulin Sensitivity [ Time Frame: Baseline and 12 weeks ]Change from baseline of adipose insulin sensitivity will be calculated as the percent suppression of free fatty acids, and the nadir of free fatty acids during the oral glucose tolerance test.
- Change in Relative Hepatic Mitochondrial Flux [ Time Frame: Baseline and 12 weeks ]Change from baseline of relative hepatic mitochondrial flux will be assessed with an oral glycerol stable isotope tracer and subsequent blood draws while fasting. The outcome will be the relative proportion of hepaticly secreted glucose and glycerol that has undergone label rearrangement representative of excess mitochondrial metabolism - termed % indirect.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919929
|Contact: Melanie Cree-Green, MD, PhD||720-777-6128||MELANIE.GREEN@UCDENVER.EDU|
|Contact: Yesenia Garcia-Reyes, MSfirstname.lastname@example.org|
|United States, Colorado|
|University of Colorado Anshutz Medical Campus/Children's Hospital Colorado|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Melanie Cree-Green, MD, PhD||Children's Hospital Colorado|