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Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Visceral fat dysfunction is an important factor in the onset of PCOS. GLP-1 receptor agonist is a glucagon-like peptide 1 analog, which is related to improving blood sugar control, weight loss and appetite suppression, and reducing cardiovascular risk. The purpose of this study was to compare whether the combined treatment of GLP-1 receptor agonists and calorie restrict diet reduced more visceral fat of overweight/obese patients with PCOS at the same weight loss (7%) compared with calorie restrict diet alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLP-1 RAs and calorie restrict diet group | Experimental | Intervention with GLP-1 RAs and calorie restrict diet until reaching the target weight loss(7%) |
|
| calorie restrict diet group | Active Comparator | Intervention with calorie restrict diet until reaching the target weight loss(7%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLP-1 RAs | Drug | GLP-1 receptor agonist is a glucagon-like peptide 1 analog, which is related to improving blood sugar control, weight loss and appetite suppression, and reducing cardiovascular risk. |
| Measure | Description | Time Frame |
|---|---|---|
| the change in visceral adipose tissue | the change in visceral adipose tissue (pretreatment-post-treatment) after achievement of the weight loss target | until achievement of the weight loss target,an average of 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| menstrual frequency | number of menstruation in a year | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| systolic blood pressure | systolic blood pressure (SBP), mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shen Qu, Dr | Shanghai 10th People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tenth People' Hospital | Shanghai | Shanghai Municipality | 200072 | 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 |
|---|---|
| C555680 | dulaglutide |
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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|
| calorie restricted diet | Other | Calorie restricted diet can improve insulin sensitivity, liver fat in patients with visceral obesity, and metabolism and hormone levels in obese women with PCOS. |
|
| from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| diastolic blood pressure | diastolic blood pressure (DBP), mmHg | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| fasting plasma glucose | fasting plasma glucose (FPG), mmol/L | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| postprandial plasma glucose | postprandial plasma glucose (PPG), mmol/L | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| fasting insulin | fasting insulin (FINS), mU/L | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| postprandial insulin | postprandial insulin (PINS), mU/L | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| glycosylated hemoglobin A1c | glycosylated hemoglobin A1c (HbA1c), % | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| homeostasis model assessment of insulin resistance | homeostasis model assessment of insulin resistance (HOMA-IR) | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| alanine aminotransferase | alanine aminotransferase (ALT), U/L | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| aspartate aminotransferase | aspartate aminotransferase (AST), U/L | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| Total cholesterol | Total cholesterol (TC), mmol/L | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| Triglycerides | Triglycerides (TG), mmol/L | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| high-density lipoprotein cholesterol | high-density lipoprotein cholesterol (HDL-c), mmol/L | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| low-density lipoprotein cholesterol | low-density lipoprotein cholesterol (LDL-c), mmol/L | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| Creatinine | Creatinine (Cr), umol/L | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| serum uric acid | serum uric acid (SUA), umol/L | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| luteinizing hormone | luteinizing hormone (LH), IU/L | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| follicle-stimulating hormone | follicle-stimulating hormone (FSH), IU/L | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| pituitary prolactin | pituitary prolactin (PRL), mIU/L | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| total testosterone | total testosterone (TT), ng/ml | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| free testosterone | free testosterone (FT), pg/ml | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| Sex hormone binding globulin | Sex hormone binding globulin (SHBG), nmol/L | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| Androstenedione | Androstenedione (AD), ng/ml | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| dehydroepiandrosterone sulfate | dehydroepiandrosterone sulfate (DHEAS), ug/dl | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| controlled attenuation parameter | controlled attenuation parameter (CAP), dB/m | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| liver stiffness measurement | liver stiffness measurement (LSM), kPa | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| total body fat | percentage of total body fat, % | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| total body lean | percentage of total body lean, % | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| total fat mass | total fat mass, kg | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| total lean mass | total lean mass, kg | from randomization to the time of achievement of the weight loss target, an average of 12 weeks |
| the change in subcutaneous adipose tissue | the change in subcutaneous adipose tissue (pretreatment-post-treatment) after achievement of the weight loss target | from randomization to the time of achievement of the weight loss target, an average of 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 |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |