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Completed

NCT Number: NCT02446834

Research of Intensive Lifestyle Intervention for PCOS Patients With IGT

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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Key information

Age range

14 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Renji Hospital Department of Endocrinology and Metabolism

Shanghai, Shanghai Municipality, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Intensive lifestyle intervention

Behavioral

3 months low GI diet and exercise

Other names: group 1

GLP-1 Receptor Agonists

Drug

Use GLP-1 Receptor Agonists 3 months to treat PCOS

Other names: group 2

metformin

Drug

Use metformin 3 months to treat PCOS

Other names: group 3

Acarbose

Drug

Use acarbose 3 months to treat PCOS

Other names: group 4

Primary outcomes

  1. changes of Islet β-cell functions from baseline

    Time frame: up to 12 weeks

    Insulin and blood glucose levels

Secondary outcomes

  1. Incretin

    Time frame: up to 12 weeks

    GLP-1, glucagon,GIP, PYY

  2. Intra-abdominal fat distribution

    Time frame: up to 12 weeks

    measured by MRI

  3. Sex Hormone

    Time frame: up to 12 weeks

    testosterone, estradiol, LH, and FSH

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
May 18, 2015
Registry last updated
Oct 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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