Treating PCOS With Semaglutide vs Active Lifestyle Intervention (TEAL)
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|ClinicalTrials.gov Identifier: NCT03919929|
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : May 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|PCOS Adolescent Obesity NAFLD||Drug: Semaglutide 3mg and 7mg [Rybelsus] 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 Semaglutide vs Active Lifestyle Intervention|
|Actual Study Start Date :||May 3, 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 take a daily oral tablet of semaglutide for 4 months.
Drug: Semaglutide 3mg and 7mg [Rybelsus]
Once daily oral tablet of semaglutide for 4 months
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.
- Evaluation of Mitochondrial function via change in ratios of direct to indirect hepatic carbon flux in newly synthesized triglycerides [ Time Frame: Baseline and 12 weeks ]OSTT with UC13 glycerol baseline and 12 weeks
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, PhDfirstname.lastname@example.org|
|Contact: Yesenia Garcia-Reyes, MSemail@example.com|
|United States, Colorado|
|University of Colorado Anshutz Medical Campus/Children's Hospital Colorado||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Yesenia Garcia Reyes 720-777-6984 firstname.lastname@example.org|
|Principal Investigator:||Melanie Cree-Green, MD, PhD||Children's Hospital Colorado|