NCT02446834

Research of Intensive Lifestyle Intervention for PCOS Patients With IGT

Research of Intensive Lifestyle Intervention for Overweight PCOS Patients With Impaired Glucose Tolerance in Their Metabolic and Reproductive Abnormalities Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: Female
• Age: 14 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	intensive lifestyle intervention	3 months low GI diet and exercise
DRUG	GLP-1 Receptor Agonists	Use GLP-1 Receptor Agonists 3 months to treat PCOS
DRUG	Metformin	Use metformin 3 months to treat PCOS
DRUG	Acarbose	Use acarbose 3 months to treat PCOS

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-12-01
• Completion: 2018-04-01
• First posted: 2015-05-18
• Last updated: 2022-10-17

Locations

1 site across 1 country: China