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 : August 11, 2022
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|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
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|Ages Eligible for Study:||12 Years to 21 Years (Child, Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Accepts Healthy Volunteers:||No|
- Sedentary- less than 2 hours of moderate (jogging, swimming etc) exercise a week.
- BMI equal or greater than the 90th percentile for age and gender
- PCOS per the most stringent NIH criteria adapted for adolescents (irregular menses >12 months post-menarche and clinical or biochemical hypertestosteronemia
- Participants cannot be on hormonal contraception, so participants should remain abstinent or use reliable non-hormonal contraception (e.g. copper IUD) for the entire study period. For participants who receive semaglutide, they should avoid pregnancy for at least 2 months after stopping medication to avoid fetal exposure to the medication.
- Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Family history of medullary thyroid cancer or thyroid nodule palpated by endocrinologist at screening.
- Use of medications known to affect insulin sensitivity: metformin (cannot have been used in the 3 months prior to screening), oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications, hormonal contraception (cannot have been used in the 6 months prior to screening). Dermal patch or vaginal ring contraception methods.Weight loss medications or stimulants. Use of other products containing other GLP-1 agonists.
- Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.
- Severe illness requiring hospitalization within 60 days.
- Diabetes, defined as Hemoglobin A1C > 6.4%
- BMI percentile less than the 90th percentile for age and sex. Weight >325 lbs. or <84 lbs.
- Anemia, defined as Hemoglobin < 11 mg/dL
- Diagnosed major psychiatric or developmental disorder limiting informed consent.
- Implanted metal devices that are not compatible with MRI
- Use of blood pressure medications.
- Known liver disease other than NAFLD or AST or ALT >100 IU/L.
- Personal history of pancreatitis
- Known renal disease of any severity or an eGFR at screening of <45ml/min/1.73m2
- History of severe GI disease (e.g. gastroparesis)
- History of gallstones
- Untreated thyroid disease
- History of hypersensitivity to semaglutide
- Other causes of hyperandrogenism (example: tumor, CAH) or amenorrhea (untreated thyroid disease, tumor, primary ovarian failure, prolactinoma).
- Active symptoms or undergoing treatment for anorexia nervosa or binging/purging disorder
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, PhDemail@example.com|
|Contact: Yesenia Garcia-Reyes, MSfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Melanie Cree-Green, MD, PhD||Children's Hospital Colorado|
|Responsible Party:||University of Colorado, Denver|
|Other Study ID Numbers:||
1R01DK120612-01A1 ( U.S. NIH Grant/Contract )
|First Posted:||April 18, 2019 Key Record Dates|
|Last Update Posted:||August 11, 2022|
|Last Verified:||August 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|