Research of Intensive Lifestyle Intervention for PCOS Patients With IGT

Sponsor

RenJi Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02446834

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Behavioral: intensive lifestyle intervention Drug: GLP-1 Receptor Agonists Drug: Metformin Drug: Acarbose	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Masking Description:

Open Label

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2015

Anticipated Primary Completion Date :

Jul 1, 2017

Anticipated Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intensive lifestyle intervention 3 months intensive lifestyle intervention, including low GI diet and exercise.	Behavioral: intensive lifestyle intervention 3 months low GI diet and exercise Other Names: group 1
Experimental: GLP-1 Receptor Agonists 3 months GLP-1 Receptor Agonists treatment	Drug: GLP-1 Receptor Agonists Use GLP-1 Receptor Agonists 3 months to treat PCOS Other Names: group 2
Experimental: metformin 3 months metformin treatment	Drug: Metformin Use metformin 3 months to treat PCOS Other Names: group 3
Experimental: acarbose 3 months acarbose treatment	Drug: Acarbose Use acarbose 3 months to treat PCOS Other Names: group 4

Outcome Measures

Primary Outcome Measures

changes of Islet β-cell functions from baseline [up to 12 weeks]
Insulin and blood glucose levels

Secondary Outcome Measures

Incretin [up to 12 weeks]
GLP-1, glucagon，GIP, PYY
Intra-abdominal fat distribution [up to 12 weeks]
Sex Hormone [up to 12 weeks]
Menstrual Cycle [up to 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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).