GLP-1 RAs in Patients With Polycystic Ovary Syndrome (PCOS)

Last updated: August 2, 2022
Sponsor: Shanghai 10th People's Hospital
Overall Status: Completed

Phase

4

Condition

Reproductive Health

Polycystic Ovarian Syndrome

Treatment

N/A

Clinical Study ID

NCT04876027
GLP-1RAs PCOS
  • Ages 18-45
  • Female

Study Summary

Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Visceral fat dysfunction is an important factor in the onset of PCOS. GLP-1 receptor agonist is a glucagon-like peptide 1 analog, which is related to improving blood sugar control, weight loss and appetite suppression, and reducing cardiovascular risk. The purpose of this study was to compare whether the combined treatment of GLP-1 receptor agonists and calorie restrict diet reduced more visceral fat of overweight/obese patients with PCOS at the same weight loss (7%) compared with calorie restrict diet alone.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female aged 18- 45;
  • Meet 2003 Rotterdam criteria;
  • overweight/obesity,BMI≥24kg/m2.

Exclusion

Exclusion Criteria:

  • any contraindication to dulaglutide (known or suspected hypersensitivity todulaglutide or related products, previous acute pancreatitis or chronic pancreatitis,inflammatory bowel disease; personal history or family history of medullary thyroidcarcinoma, or personal history of multiple endocrine neoplasia type 2)；
  • treatment with any other drugs that may interfere with the trial, includingtraditional Chinese medicine, contraceptives, metformin, GLP-1RA or pioglitazonewithin the last 3 months；
  • chronic kidney disease or severe liver dysfunction；
  • malignant tumors；
  • mental illness;
  • pregnancy or lactation；
  • inflammatory bowel disease;
  • recent participation in other weight-loss research projects within the last 3 months.

Study Design

Total Participants: 68
Study Start date:
May 15, 2021
Estimated Completion Date:
May 10, 2022

Connect with a study center

  • Shanghai Tenth People' Hospital

    Shanghai, Shanghai 200072
    China

    Site Not Available

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