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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
3 months low GI diet and exercise
Use GLP-1 Receptor Agonists 3 months to treat PCOS
Use metformin 3 months to treat PCOS
Renji Hospital Department of Endocrinology and Metabolism
Shanghai, Shanghai Municipality, China
changes of Islet β-cell functions from baseline
Insulin and blood glucose levels
Time frame: up to 12 weeks
Incretin
GLP-1, glucagon，GIP, PYY
Time frame: up to 12 weeks
Intra-abdominal fat distribution
measured by MRI
Time frame: up to 12 weeks
Sex Hormone
testosterone, estradiol, LH, and FSH
Time frame: up to 12 weeks
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Use acarbose 3 months to treat PCOS