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

NCT04876027 | Completed Phase 4 DMC

• 1 other identifier: GLP-1RAs PCOS
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• the change in visceral adipose tissue

  the change in visceral adipose tissue (pretreatment-post-treatment) after achievement of the weight loss target

  until achievement of the weight loss target,an average of 12 weeks

Secondary Outcomes (32)

• menstrual frequency

  from randomization to the time of achievement of the weight loss target, an average of 12 weeks

• systolic blood pressure

  from randomization to the time of achievement of the weight loss target, an average of 12 weeks

• diastolic blood pressure

  from randomization to the time of achievement of the weight loss target, an average of 12 weeks

• fasting plasma glucose

  from randomization to the time of achievement of the weight loss target, an average of 12 weeks

• postprandial plasma glucose

  from randomization to the time of achievement of the weight loss target, an average of 12 weeks

Study Arms (2)

GLP-1 RAs and calorie restrict diet group

EXPERIMENTAL

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

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

calorie restrict diet group

ACTIVE COMPARATOR

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

Other: calorie restricted diet

Interventions

GLP-1 RAs 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.

Also known as: Dulaglutide

GLP-1 RAs and calorie restrict diet group

calorie restricted diet 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.

GLP-1 RAs and calorie restrict diet group; calorie restrict diet group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People' Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

dulaglutide; Caloric Restriction

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Shen Qu, Dr

  Shanghai 10th People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 6, 2021
• Study Start: May 15, 2021
• Primary Completion: April 30, 2022
• Study Completion: May 10, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)