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Research of Intensive Lifestyle Intervention for PCOS Patients With IGT

Primary Purpose

Polycystic Ovary Syndrome

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

intensive lifestyle intervention

GLP-1 Receptor Agonists

Metformin

Acarbose

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, intensive lifestyle intervention, IGT, drugs treatment

Eligibility Criteria

14 Years - 50 Years (Child, Adult)FemaleDoes not accept 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).

Sites / Locations

Renji Hospital Department of Endocrinology and Metabolism

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

intensive lifestyle intervention

GLP-1 Receptor Agonists

metformin

acarbose

Arm Description

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

3 months GLP-1 Receptor Agonists treatment

3 months metformin treatment

3 months acarbose treatment

Outcomes

Primary Outcome Measures

changes of Islet β-cell functions from baseline

Insulin and blood glucose levels

Secondary Outcome Measures

Incretin

GLP-1, glucagon，GIP, PYY

Intra-abdominal fat distribution

measured by MRI

Sex Hormone

testosterone, estradiol, LH, and FSH

Full Information

NCT ID

NCT02446834

First Posted

May 6, 2015

Last Updated

October 13, 2022

Sponsor

RenJi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02446834

Brief Title

Research of Intensive Lifestyle Intervention for PCOS Patients With IGT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

April 2015 (Actual)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RenJi Hospital

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome

Keywords

PCOS, intensive lifestyle intervention, IGT, drugs treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Masking Description

Open Label

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

intensive lifestyle intervention

Arm Type

Experimental

Arm Description

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

Arm Title

GLP-1 Receptor Agonists

Arm Type

Experimental

Arm Description

3 months GLP-1 Receptor Agonists treatment

Arm Title

metformin

Arm Type

Experimental

Arm Description

3 months metformin treatment

Arm Title

acarbose

Arm Type

Experimental

Arm Description

3 months acarbose treatment

Intervention Type

Behavioral

Intervention Name(s)

intensive lifestyle intervention

Other Intervention Name(s)

group 1

Intervention Description

3 months low GI diet and exercise

Intervention Type

Drug

Intervention Name(s)

GLP-1 Receptor Agonists

Other Intervention Name(s)

group 2

Intervention Description

Use GLP-1 Receptor Agonists 3 months to treat PCOS

Intervention Type

Drug

Intervention Name(s)

Metformin

Other Intervention Name(s)

group 3

Intervention Description

Use metformin 3 months to treat PCOS

Intervention Type

Drug

Intervention Name(s)

Acarbose

Other Intervention Name(s)

group 4

Intervention Description

Use acarbose 3 months to treat PCOS

Primary Outcome Measure Information:

Title

changes of Islet β-cell functions from baseline

Description

Insulin and blood glucose levels

Time Frame

up to 12 weeks

Secondary Outcome Measure Information:

Title

Incretin

Description

GLP-1, glucagon，GIP, PYY

Time Frame

up to 12 weeks

Title

Intra-abdominal fat distribution

Description

measured by MRI

Time Frame

up to 12 weeks

Title

Sex Hormone

Description

testosterone, estradiol, LH, and FSH

Time Frame

up to 12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tao Tao, MD

Organizational Affiliation

RenJi Hospital Department of Endocrinology and Metabolism

Official's Role

Study Chair

Facility Information:

Facility Name

Renji Hospital Department of Endocrinology and Metabolism

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200127

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Research of Intensive Lifestyle Intervention for PCOS Patients With IGT

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