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

NCT ID: NCT04876027

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2022-05-10

Brief 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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GLP-1 RAs and calorie restrict diet group

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

Group Type: EXPERIMENTAL

GLP-1 RAs

Intervention Type: DRUG

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.

calorie restricted diet

Intervention Type: OTHER

Calorie restricted diet can improve insulin sensitivity, liver fat in patients with visceral obesity, and metabolism and hormone levels in obese women with PCOS.

calorie restrict diet group

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

Group Type: ACTIVE_COMPARATOR

calorie restricted diet

Intervention Type: OTHER

Calorie restricted diet can improve insulin sensitivity, liver fat in patients with visceral obesity, and metabolism and hormone levels in obese women with PCOS.

Interventions

GLP-1 RAs

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.

Intervention Type: DRUG

calorie restricted diet

Calorie restricted diet can improve insulin sensitivity, liver fat in patients with visceral obesity, and metabolism and hormone levels in obese women with PCOS.

Intervention Type: OTHER

Other Intervention Names

Dulaglutide

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhang Manna

Director, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shen Qu, Dr

Role: STUDY_CHAIR

Shanghai 10th People's Hospital

Locations

Shanghai Tenth People' Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

GLP-1RAs PCOS

Identifier Type: -

Identifier Source: org_study_id