GLP-1 RAs in Patients With Polycystic Ovary Syndrome (PCOS)
- Conditions
- Polycystic Ovary Syndrome
- Interventions
- Other: calorie restricted diet
- Registration Number
- NCT04876027
- Lead Sponsor
- Shanghai 10th People's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 68
- Female aged 18- 45;
- Meet 2003 Rotterdam criteria;
- overweight/obesity,BMI≥24kg/m2.
- 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)；
- 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；
- chronic kidney disease or severe liver dysfunction；
- malignant tumors；
- mental illness;
- pregnancy or lactation；
- inflammatory bowel disease;
- recent participation in other weight-loss research projects within the last 3 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GLP-1 RAs and calorie restrict diet group GLP-1 RAs Intervention with GLP-1 RAs and calorie restrict diet until reaching the target weight loss(7%) GLP-1 RAs and calorie restrict diet group calorie restricted diet Intervention with GLP-1 RAs and calorie restrict diet until reaching the target weight loss(7%) calorie restrict diet group calorie restricted diet Intervention with calorie restrict diet until reaching the target weight loss(7%)
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
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 insulin from randomization to the time of achievement of the weight loss target, an average of 12 weeks fasting insulin (FINS), mU/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
Androstenedione from randomization to the time of achievement of the weight loss target, an average of 12 weeks Androstenedione (AD), ng/ml
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
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
postprandial insulin from randomization to the time of achievement of the weight loss target, an average of 12 weeks postprandial insulin (PINS), mU/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
Creatinine from randomization to the time of achievement of the weight loss target, an average of 12 weeks Creatinine (Cr), umol/L
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
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 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
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
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
glycosylated hemoglobin A1c from randomization to the time of achievement of the weight loss target, an average of 12 weeks glycosylated hemoglobin A1c (HbA1c), %
alanine aminotransferase from randomization to the time of achievement of the weight loss target, an average of 12 weeks alanine aminotransferase (ALT), U/L
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)
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
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
free testosterone from randomization to the time of achievement of the weight loss target, an average of 12 weeks free testosterone (FT), pg/ml
total testosterone from randomization to the time of achievement of the weight loss target, an average of 12 weeks total testosterone (TT), ng/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
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 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
Trial Locations
- Locations (1)
Shanghai Tenth People' Hospital
🇨🇳Shanghai, Shanghai, China