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

Tongji University

Status and phase: Completed; Phase 4

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: GLP-1 RAs; Other: calorie restricted diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04876027

GLP-1RAs PCOS

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• any contraindication to dulaglutide (known or suspected hypersensitivity to dulaglutide or related products, previous acute pancreatitis or chronic pancreatitis, inflammatory bowel disease; personal history or family history of medullary thyroid carcinoma, or personal history of multiple endocrine neoplasia type 2)；
• treatment with any other drugs that may interfere with the trial, including traditional Chinese medicine, contraceptives, metformin, GLP-1RA or pioglitazone within 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

GLP-1 RAs and calorie restrict diet group

Experimental group

Description:

Intervention with GLP-1 RAs and calorie restrict diet until reaching the target weight loss(7%)

Treatment:

Other: calorie restricted diet

Drug: GLP-1 RAs

calorie restrict diet group

Active Comparator group

Description:

Intervention with calorie restrict diet until reaching the target weight loss(7%)

Treatment:

Other: calorie restricted diet