Research of Intensive Lifestyle Intervention for PCOS Patients With IGT

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02446834
• Other study ID #: [2015]018K
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: April 2018

Study information

• Verified date: November 2017
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

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
• Metformin
Use metformin 3 months to treat PCOS
• Acarbose
Use acarbose 3 months to treat PCOS

Locations

Country	Name	City	State
China	Renji Hospital Department of Endocrinology and Metabolism	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of Islet ß-cell functions from baseline	Insulin and blood glucose levels	up to 12 weeks
Secondary	Incretin	GLP-1, glucagon,GIP, PYY	up to 12 weeks
Secondary	Intra-abdominal fat distribution	measured by MRI	up to 12 weeks
Secondary	Sex Hormone	testosterone, estradiol, LH, and FSH	up to 12 weeks