Research of Intensive Lifestyle Intervention for PCOS Patients With IGT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-04-30

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.

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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.

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open Label

Study Groups

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intensive lifestyle intervention

3 months intensive lifestyle intervention, including low GI diet and exercise.

Group Type EXPERIMENTAL

intensive lifestyle intervention

Intervention Type BEHAVIORAL

3 months low GI diet and exercise

GLP-1 Receptor Agonists

3 months GLP-1 Receptor Agonists treatment

Group Type EXPERIMENTAL

GLP-1 Receptor Agonists

Intervention Type DRUG

Use GLP-1 Receptor Agonists 3 months to treat PCOS

metformin

3 months metformin treatment

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Use metformin 3 months to treat PCOS

acarbose

3 months acarbose treatment

Group Type EXPERIMENTAL

Acarbose

Intervention Type DRUG

Use acarbose 3 months to treat PCOS

Interventions

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intensive lifestyle intervention

3 months low GI diet and exercise

Intervention Type BEHAVIORAL

GLP-1 Receptor Agonists

Use GLP-1 Receptor Agonists 3 months to treat PCOS

Intervention Type DRUG

Metformin

Use metformin 3 months to treat PCOS

Intervention Type DRUG

Acarbose

Use acarbose 3 months to treat PCOS

Intervention Type DRUG

Other Intervention Names

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group 1 group 2 group 3 group 4

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).

Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No