Research of Intensive Lifestyle Intervention for PCOS Patients With IGT

Shanghai Jiao Tong University

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Behavioral: intensive lifestyle intervention; Drug: GLP-1 Receptor Agonists; Drug: Acarbose; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02446834

[2015]018K

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 14 to 50 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

intensive lifestyle intervention

Experimental group

Description:

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

Treatment:

Behavioral: intensive lifestyle intervention

GLP-1 Receptor Agonists

Experimental group

Description:

3 months GLP-1 Receptor Agonists treatment

Treatment:

Drug: GLP-1 Receptor Agonists

metformin

Experimental group

Description:

3 months metformin treatment

Treatment:

Drug: Metformin

acarbose

Experimental group

Description:

3 months acarbose treatment

Treatment:

Drug: Acarbose