GLP-1 RAs in Patients With Polycystic Ovary Syndrome (PCOS)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GLP-1 RAs and calorie restrict diet group Intervention with GLP-1 RAs and calorie restrict diet until reaching the target weight loss(7%) |
Drug: GLP-1 RAs
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.
Other Names:
Other: calorie restricted diet
Calorie restricted diet can improve insulin sensitivity, liver fat in patients with visceral obesity, and metabolism and hormone levels in obese women with PCOS.
|
| Active Comparator: calorie restrict diet group Intervention with calorie restrict diet until reaching the target weight loss(7%) |
Other: calorie restricted diet
Calorie restricted diet can improve insulin sensitivity, liver fat in patients with visceral obesity, and metabolism and hormone levels in obese women with PCOS.
|
Outcome Measures
Primary Outcome Measures
- the change in visceral adipose tissue [until achievement of the weight loss target,an average of 12 weeks]
the change in visceral adipose tissue (pretreatment-post-treatment) after achievement of the weight loss target
Secondary Outcome Measures
- menstrual frequency [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
number of menstruation in a year
- systolic blood pressure [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
systolic blood pressure (SBP), mmHg
- diastolic blood pressure [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
diastolic blood pressure (DBP), mmHg
- fasting plasma glucose [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
fasting plasma glucose (FPG), mmol/L
- postprandial plasma glucose [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
postprandial plasma glucose (PPG), mmol/L
- fasting insulin [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
fasting insulin (FINS), mU/L
- postprandial insulin [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
postprandial insulin (PINS), mU/L
- glycosylated hemoglobin A1c [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
glycosylated hemoglobin A1c (HbA1c), %
- homeostasis model assessment of insulin resistance [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
homeostasis model assessment of insulin resistance (HOMA-IR)
- alanine aminotransferase [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
alanine aminotransferase (ALT), U/L
- aspartate aminotransferase [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
aspartate aminotransferase (AST), U/L
- Total cholesterol [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
Total cholesterol (TC), mmol/L
- Triglycerides [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
Triglycerides (TG), mmol/L
- high-density lipoprotein cholesterol [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
high-density lipoprotein cholesterol (HDL-c), mmol/L
- low-density lipoprotein cholesterol [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
low-density lipoprotein cholesterol (LDL-c), mmol/L
- Creatinine [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
Creatinine (Cr), umol/L
- serum uric acid [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
serum uric acid (SUA), umol/L
- luteinizing hormone [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
luteinizing hormone (LH), IU/L
- follicle-stimulating hormone [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
follicle-stimulating hormone (FSH), IU/L
- pituitary prolactin [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
pituitary prolactin (PRL), mIU/L
- total testosterone [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
total testosterone (TT), ng/ml
- free testosterone [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
free testosterone (FT), pg/ml
- Sex hormone binding globulin [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
Sex hormone binding globulin (SHBG), nmol/L
- Androstenedione [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
Androstenedione (AD), ng/ml
- dehydroepiandrosterone sulfate [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
dehydroepiandrosterone sulfate (DHEAS), ug/dl
- controlled attenuation parameter [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
controlled attenuation parameter (CAP), dB/m
- liver stiffness measurement [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
liver stiffness measurement (LSM), kPa
- total body fat [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
percentage of total body fat, %
- total body lean [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
percentage of total body lean, %
- total fat mass [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
total fat mass, kg
- total lean mass [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
total lean mass, kg
- the change in subcutaneous adipose tissue [from randomization to the time of achievement of the weight loss target, an average of 12 weeks]
the change in subcutaneous adipose tissue (pretreatment-post-treatment) after achievement of the weight loss target
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female aged 18- 45;
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Meet 2003 Rotterdam criteria;
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overweight/obesity,BMI≥24kg/m2.
Exclusion Criteria:
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any contraindication to dulaglutide (known or suspected hypersensitivity to dulaglutide or related products, previous acute pancreatitis or chronic pancreatitis, inflammatory bowel disease; personal history or family history of medullary thyroid carcinoma, or personal history of multiple endocrine neoplasia type 2)；
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treatment with any other drugs that may interfere with the trial, including traditional Chinese medicine, contraceptives, metformin, GLP-1RA or pioglitazone within the last 3 months；
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chronic kidney disease or severe liver dysfunction；
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malignant tumors；
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mental illness;
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pregnancy or lactation；
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inflammatory bowel disease;
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recent participation in other weight-loss research projects within the last 3 months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Tenth People' Hospital | Shanghai | Shanghai | China | 200072 |
Sponsors and Collaborators
- Shanghai 10th People's Hospital
Investigators
- Study Chair: Shen Qu, Dr, Shanghai 10th People's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GLP-1RAs PCOS