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

• Status: Enrolling by invitation
• Trial end date: 2022-05-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai 10th People's Hospital
• Treatments: Dulaglutide

Criteria

Inclusion Criteria:

• Female aged 18- 45;

• Meet Rotterdam criteria;

• overweight/obesity,BMI≥25kg/m2

Exclusion Criteria:

• Those who are allergic to the active ingredients of GLP-1 receptor agonists or any other excipients; patients with a history or family history of medullary thyroid carcinoma; patients with type 2 multiple endocrine tumor syndrome;

• Patients with type 1 or type 2 diabetes or diabetic ketoacidosis;

• Pregnancy, planned pregnancy and breastfeeding women, children;

• Uncontrolled hypertension (systolic/diastolic blood pressure is 140/90 mmHg);

• Active heart disease occurred within 3 months;

• Inflammatory bowel disease, diabetic gastritis or other serious gastrointestinal diseases;

• Liver disease, AST or ALT level is twice higher than the upper limit of normal;

• Kidney disease, creatinine clearance rate is less than 60mL/min;

• Active or untreated malignant tumors;

• Acute or chronic pancreatitis;

• Hemoglobinopathies; hemolytic or chronic anemia;

• Severe hypoglycemia occurred twice or more within 6 months;

• Eliminate the use of any drugs that may interfere with the test results (insulin, α-glucosidase inhibitor, megtinib, DPP-4 inhibitor, GLP-1 receptor agonist or rosiglitazone)

• Have received surgical treatment for obesity;

• Smoking or using any nicotine product; drinking alcohol

• Expect lifestyle changes (such as diet, exercise, or sleep patterns) during the trial.

• Currently or recently participating in another clinical trial.