Research of Intensive Lifestyle Intervention for PCOS Patients With IGT

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02446834

Enrollment

Registered

2015-05-18

Start date

2015-04-30

Completion date

2018-04-30

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS, intensive lifestyle intervention, IGT, drugs treatment

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.

Interventions

BEHAVIORALintensive lifestyle intervention

3 months low GI diet and exercise

DRUGGLP-1 Receptor Agonists

Use GLP-1 Receptor Agonists 3 months to treat PCOS

DRUGMetformin

Use metformin 3 months to treat PCOS

DRUGAcarbose

Use acarbose 3 months to treat PCOS

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Masking description

Open Label

Eligibility

Sex/Gender

FEMALE

Age

14 Years to 50 Years

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).

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026