GLP-1 RAs in Patients With Polycystic Ovary Syndrome (PCOS)

Study Overview
=================
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.

Official Title
-----------------
Dulaglutide and Calorie Restrict Diet (CRD) in Overweight/Obese Patients With Polycystic Ovary Syndrome

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: GLP-1 RAs
* Other: calorie restricted diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female aged 18- 45; Meet 2003 Rotterdam criteria; overweight/obesity,BMI≥24kg/m2. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLP-1 RAs and calorie restrict diet group<br>Intervention with GLP-1 RAs and calorie restrict diet until reaching the target weight loss(7%) | Drug: GLP-1 RAs<br>* 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.<br>* Other names: Dulaglutide;Other: calorie restricted diet<br>* Calorie restricted diet can improve insulin sensitivity, liver fat in patients with visceral obesity, and metabolism and hormone levels in obese women with PCOS.<br>|
| Active Comparator: calorie restrict diet group<br>Intervention with calorie restrict diet until reaching the target weight loss(7%) | Other: calorie restricted diet<br>* Calorie restricted diet can improve insulin sensitivity, liver fat in patients with visceral obesity, and metabolism and hormone levels in obese women with PCOS.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |