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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intensive lifestyle intervention | Experimental | 3 months intensive lifestyle intervention, including low GI diet and exercise. |
|
| GLP-1 Receptor Agonists | Experimental | 3 months GLP-1 Receptor Agonists treatment |
|
| metformin | Experimental | 3 months metformin treatment |
|
| acarbose | Experimental | 3 months acarbose treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intensive lifestyle intervention | Behavioral | 3 months low GI diet and exercise |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes of Islet β-cell functions from baseline | Insulin and blood glucose levels | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incretin | GLP-1, glucagon,GIP, PYY | up to 12 weeks |
| Intra-abdominal fat distribution | measured by MRI | up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tao Tao, MD | RenJi Hospital Department of Endocrinology and Metabolism | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital Department of Endocrinology and Metabolism | Shanghai | Shanghai Municipality | 200127 | China |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D000097789 | Glucagon-Like Peptide-1 Receptor Agonists |
| D008687 | Metformin |
| D020909 | Acarbose |
| ID | Term |
|---|---|
| D007004 | Hypoglycemic Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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Open Label
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| GLP-1 Receptor Agonists | Drug | Use GLP-1 Receptor Agonists 3 months to treat PCOS |
|
|
| Metformin | Drug | Use metformin 3 months to treat PCOS |
|
|
| Acarbose | Drug | Use acarbose 3 months to treat PCOS |
|
|
| Sex Hormone | testosterone, estradiol, LH, and FSH | up to 12 weeks |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |