Clinical trial NCT04876027: GLP-1 RAs in Patients With Polycystic Ovary Syndrome (PCOS)
Official title: Dulaglutide and Calorie Restrict Diet (CRD) in Overweight/Obese Patients With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: the change in visceral adipose tissue
timeFrame: until achievement of the weight loss target,an average of 12 weeks
Secondary outcomes:
measure: menstrual frequency
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: systolic blood pressure
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: diastolic blood pressure
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: fasting plasma glucose
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: postprandial plasma glucose
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: fasting insulin
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: postprandial insulin
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: glycosylated hemoglobin A1c
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: homeostasis model assessment of insulin resistance
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: alanine aminotransferase
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: aspartate aminotransferase
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: Total cholesterol
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: Triglycerides
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: high-density lipoprotein cholesterol
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: low-density lipoprotein cholesterol
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: Creatinine
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: serum uric acid
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: luteinizing hormone
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: follicle-stimulating hormone
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: pituitary prolactin
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: total testosterone
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: free testosterone
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: Sex hormone binding globulin
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: Androstenedione
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: dehydroepiandrosterone sulfate
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: controlled attenuation parameter
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: liver stiffness measurement
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: total body fat
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: total body lean
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: total fat mass
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: total lean mass
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
measure: the change in subcutaneous adipose tissue
timeFrame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People' Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Shen Qu, Dr
role: STUDY_CHAIR
References: