Clinical trial NCT02446834: 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
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
intensive lifestyle intervention
IGT
drugs treatment
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2015-05-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: 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.

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).

Primary outcomes:
measure: changes of Islet β-cell functions from baseline
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Incretin
timeFrame: up to 12 weeks
measure: Intra-abdominal fat distribution
timeFrame: up to 12 weeks
measure: Sex Hormone
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital Department of Endocrinology and Metabolism
state: Shanghai
Study officials:
affiliation: RenJi Hospital Department of Endocrinology and Metabolism
name: Tao Tao, MD
role: STUDY_CHAIR
References: