Research of Intensive Lifestyle Intervention for PCOS Patients With IGT

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Acarbose; Drug: GLP-1 Receptor Agonists; Behavioral: intensive lifestyle intervention; Drug: Metformin

• Registration Number: NCT02446834
• Lead Sponsor: RenJi Hospital

Brief Summary

Compare the efficacy between intensive lifestyle intervention and drugs (GLP-1 Receptor Agonists, metformin and acarbose) for PCOS patients with early onset diabetes in their metabolic and reproductive abnormalities treatment; clear the treatment effect and mechanism of intensive lifestyle intervention to PCOS.

Detailed Description

We designed a non randomized control study to compare the efficacy between intensive lifestyle intervention and drugs (GLP-1 Receptor Agonists, metformin and acarbose) for PCOS patients with early onset diabetes in their metabolic and reproductive abnormalities treatment We planed to enroll 48 patients.Overweight and obese PCOS patients with newly diagnosed IGT; PCOS diagnosis based on 1990 NIH criteria. Overweight / obesity diagnostic criteria according to WHO-WPR. IGT diagnostic criteria according to 1998 WHO diagnostic criteria. Except for serious complications (cardiovascular events and recent significant kidney or lung disease within 3 months), and had high blood pressure (\>160/100mmHg), blood sugar and high blood lipids (glycated hemoglobin\> 11%, triglycerides \>600 mg/dl).

Then we devided the 48 patients into 4 groups: intensive lifestyle intervention group, GLP-1 group, metformin group and acarbose group, and each group 12 samples. Each group use specific treatment(showed as the group name) 3 months. Before and after the intervention, the blood samples would be collected to Glucose, Insulin, GLP-1, Glucagon, sex hormones, Blood chemistry for liver and kidney function ect, as well as the image examinations.

We will compare the data of each patient, finally identify the treatment effect and mechanism of intensive lifestyle intervention to PCOS.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-13
• Study First Posted: 2015-05-18
• Status Verified: 2017-11
• Primary Completion: 2017-12
• Study Completion: 2018-04
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Overweight and obese PCOS patients with newly diagnosed IGT; PCOS diagnosis based on 1990 NIH criteria. Overweight / obesity diagnostic criteria according to WHO-WPR. IGT diagnostic criteria according to 1998 WHO diagnostic criteria.

Exclusion Criteria

• Except for serious complications (cardiovascular events and recent significant kidney or lung disease within 3 months), and had high blood pressure (>160/100mmHg), blood sugar and high blood lipids (glycated hemoglobin> 11%, triglycerides >600 mg/dl).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
acarbose	Acarbose	3 months acarbose treatment
GLP-1 Receptor Agonists	GLP-1 Receptor Agonists	3 months GLP-1 Receptor Agonists treatment
intensive lifestyle intervention	intensive lifestyle intervention	3 months intensive lifestyle intervention, including low GI diet and exercise.
metformin	Metformin	3 months metformin treatment

Primary Outcome Measures

Name	Time	Method
changes of Islet β-cell functions from baseline	up to 12 weeks	Insulin and blood glucose levels

Secondary Outcome Measures

Name	Time	Method
Incretin	up to 12 weeks	GLP-1, glucagon，GIP, PYY
Intra-abdominal fat distribution	up to 12 weeks	measured by MRI
Sex Hormone	up to 12 weeks	testosterone, estradiol, LH, and FSH

Trial Locations

Locations (1)

Renji Hospital Department of Endocrinology and Metabolism; 🇨🇳 Shanghai, Shanghai, China