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

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

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Drug: GLP-1 RAs; Other: calorie restricted diet

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Shanghai Tenth People' Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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: Dulaglutide; 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.

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

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Study Chair: Shen Qu, Dr, Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): May 10, 2022

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome; Hypoglycemic Agents; Physiological Effects of Drugs; Dulaglutide
• Other Study ID Numbers: GLP-1RAs PCOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No