Treating PCOS With Semaglutide vs Active Lifestyle Intervention

  • STATUS
    Recruiting
  • End date
    Jul 31, 2024
  • participants needed
    50
  • sponsor
    University of Colorado, Denver
Updated on 2 June 2021
insulin
metabolic syndrome
insulin sensitivity
glucagon
fats
dietary modification
dietary intervention
semaglutide
weight loss diet
rybelsus
receptor agonist therapy

Summary

Girls with obesity and polycystic ovarian syndrome will receive either glucagon like peptide-1 receptor agonist therapy or a dietary intervention for 12 weeks to decrease the metabolic syndrome, in particular to lower hepatic fat and improve insulin sensitivity.

Description

In obese girls with polycystic ovarian syndrome, testosterone and obesity combine to create unique pathology to increase metabolic disease including fatty liver and insulin resistance, which may be mediated by altered glucagon like peptide-1 activity. The investigators will treat girls with obesity and polycystic ovarian syndrome for 4 months with a glucagon like peptide-1 receptor agonist compared to dietary intervention to primarily lower hepatic fat and secondarily improve whole body and adipose insulin sensitivity. Mechanisms of hepatic metabolism, including rates of de novo lipogenesis and relative mitochondrial flux will also be assessed.

Details
Condition non-alcoholic fatty liver, Adolescent Obesity, pcos, Nonalcoholic Steatohepatitis (NASH), polycystic ovary disease, Polycystic Ovary Syndrome, Obesity, Non-alcoholic Fatty Liver Disease, Nonalcoholic Fatty Liver Disease, NAFLD, Polycystic Ovarian Syndrome
Treatment Weight Loss Diet, Semaglutide 3mg and 7mg [Rybelsus]
Clinical Study IdentifierNCT03919929
SponsorUniversity of Colorado, Denver
Last Modified on2 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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