Research of Intensive Lifestyle Intervention for PCOS Patients With IGT

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Behavioral: intensive lifestyle intervention
* Drug: GLP-1 Receptor Agonists
* Drug: Metformin
* Drug: Acarbose


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intensive lifestyle intervention<br>3 months intensive lifestyle intervention, including low GI diet and exercise. | Behavioral: intensive lifestyle intervention<br>* 3 months low GI diet and exercise<br>* Other names: group 1;|
| Experimental: GLP-1 Receptor Agonists<br>3 months GLP-1 Receptor Agonists treatment | Drug: GLP-1 Receptor Agonists<br>* Use GLP-1 Receptor Agonists 3 months to treat PCOS<br>* Other names: group 2;|
| Experimental: metformin<br>3 months metformin treatment | Drug: Metformin<br>* Use metformin 3 months to treat PCOS<br>* Other names: group 3;|
| Experimental: acarbose<br>3 months acarbose treatment | Drug: Acarbose<br>* Use acarbose 3 months to treat PCOS<br>* Other names: group 4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of Islet β-cell functions from baseline | Insulin and blood glucose levels | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incretin | GLP-1, glucagon，GIP, PYY | up to 12 weeks | 
| Intra-abdominal fat distribution | measured by MRI | up to 12 weeks | 
| Sex Hormone | testosterone, estradiol, LH, and FSH | up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, intensive lifestyle intervention, IGT, drugs treatment