Renji Hospital Department of Endocrinology and Metabolism
Shanghai, Shanghai Municipality, 200127, China
NCT Number: NCT02446834
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.
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Notify Me14 year–50 year
Female
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200127, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3 months low GI diet and exercise
Other names: group 1
Use GLP-1 Receptor Agonists 3 months to treat PCOS
Other names: group 2
Use metformin 3 months to treat PCOS
Other names: group 3
Use acarbose 3 months to treat PCOS
Other names: group 4
Time frame: up to 12 weeks
Insulin and blood glucose levels
Time frame: up to 12 weeks
GLP-1, glucagon,GIP, PYY
Time frame: up to 12 weeks
measured by MRI
Time frame: up to 12 weeks
testosterone, estradiol, LH, and FSH
RenJi Hospital
Other
Research of Intensive Lifestyle Intervention for Overweight PCOS Patients With Impaired Glucose Tolerance in Their Metabolic and Reproductive Abnormalities Treatment
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