search
Back to results

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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
GLP-1 RAs
calorie restricted diet
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Tenth People' Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GLP-1 RAs and calorie restrict diet group

calorie restrict diet group

Arm Description

Intervention with GLP-1 RAs and calorie restrict diet until reaching the target weight loss(7%)

Intervention with calorie restrict diet until reaching the target weight loss(7%)

Outcomes

Primary Outcome Measures

the change in visceral adipose tissue
the change in visceral adipose tissue (pretreatment-post-treatment) after achievement of the weight loss target

Secondary Outcome Measures

menstrual frequency
number of menstruation in a year
systolic blood pressure
systolic blood pressure (SBP), mmHg
diastolic blood pressure
diastolic blood pressure (DBP), mmHg
fasting plasma glucose
fasting plasma glucose (FPG), mmol/L
postprandial plasma glucose
postprandial plasma glucose (PPG), mmol/L
fasting insulin
fasting insulin (FINS), mU/L
postprandial insulin
postprandial insulin (PINS), mU/L
glycosylated hemoglobin A1c
glycosylated hemoglobin A1c (HbA1c), %
homeostasis model assessment of insulin resistance
homeostasis model assessment of insulin resistance (HOMA-IR)
alanine aminotransferase
alanine aminotransferase (ALT), U/L
aspartate aminotransferase
aspartate aminotransferase (AST), U/L
Total cholesterol
Total cholesterol (TC), mmol/L
Triglycerides
Triglycerides (TG), mmol/L
high-density lipoprotein cholesterol
high-density lipoprotein cholesterol (HDL-c), mmol/L
low-density lipoprotein cholesterol
low-density lipoprotein cholesterol (LDL-c), mmol/L
Creatinine
Creatinine (Cr), umol/L
serum uric acid
serum uric acid (SUA), umol/L
luteinizing hormone
luteinizing hormone (LH), IU/L
follicle-stimulating hormone
follicle-stimulating hormone (FSH), IU/L
pituitary prolactin
pituitary prolactin (PRL), mIU/L
total testosterone
total testosterone (TT), ng/ml
free testosterone
free testosterone (FT), pg/ml
Sex hormone binding globulin
Sex hormone binding globulin (SHBG), nmol/L
Androstenedione
Androstenedione (AD), ng/ml
dehydroepiandrosterone sulfate
dehydroepiandrosterone sulfate (DHEAS), ug/dl
controlled attenuation parameter
controlled attenuation parameter (CAP), dB/m
liver stiffness measurement
liver stiffness measurement (LSM), kPa
total body fat
percentage of total body fat, %
total body lean
percentage of total body lean, %
total fat mass
total fat mass, kg
total lean mass
total lean mass, kg
the change in subcutaneous adipose tissue
the change in subcutaneous adipose tissue (pretreatment-post-treatment) after achievement of the weight loss target

Full Information

First Posted
April 29, 2021
Last Updated
August 2, 2022
Sponsor
Shanghai 10th People's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04876027
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
May 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GLP-1 RAs and calorie restrict diet group
Arm Type
Experimental
Arm Description
Intervention with GLP-1 RAs and calorie restrict diet until reaching the target weight loss(7%)
Arm Title
calorie restrict diet group
Arm Type
Active Comparator
Arm Description
Intervention with calorie restrict diet until reaching the target weight loss(7%)
Intervention Type
Drug
Intervention Name(s)
GLP-1 RAs
Other Intervention Name(s)
Dulaglutide
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
calorie restricted diet
Intervention Description
Calorie restricted diet can improve insulin sensitivity, liver fat in patients with visceral obesity, and metabolism and hormone levels in obese women with PCOS.
Primary Outcome Measure Information:
Title
the change in visceral adipose tissue
Description
the change in visceral adipose tissue (pretreatment-post-treatment) after achievement of the weight loss target
Time Frame
until achievement of the weight loss target,an average of 12 weeks
Secondary Outcome Measure Information:
Title
menstrual frequency
Description
number of menstruation in a year
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
systolic blood pressure
Description
systolic blood pressure (SBP), mmHg
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
diastolic blood pressure
Description
diastolic blood pressure (DBP), mmHg
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
fasting plasma glucose
Description
fasting plasma glucose (FPG), mmol/L
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
postprandial plasma glucose
Description
postprandial plasma glucose (PPG), mmol/L
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
fasting insulin
Description
fasting insulin (FINS), mU/L
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
postprandial insulin
Description
postprandial insulin (PINS), mU/L
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
glycosylated hemoglobin A1c
Description
glycosylated hemoglobin A1c (HbA1c), %
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
homeostasis model assessment of insulin resistance
Description
homeostasis model assessment of insulin resistance (HOMA-IR)
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
alanine aminotransferase
Description
alanine aminotransferase (ALT), U/L
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
aspartate aminotransferase
Description
aspartate aminotransferase (AST), U/L
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
Total cholesterol
Description
Total cholesterol (TC), mmol/L
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
Triglycerides
Description
Triglycerides (TG), mmol/L
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
high-density lipoprotein cholesterol
Description
high-density lipoprotein cholesterol (HDL-c), mmol/L
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
low-density lipoprotein cholesterol
Description
low-density lipoprotein cholesterol (LDL-c), mmol/L
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
Creatinine
Description
Creatinine (Cr), umol/L
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
serum uric acid
Description
serum uric acid (SUA), umol/L
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
luteinizing hormone
Description
luteinizing hormone (LH), IU/L
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
follicle-stimulating hormone
Description
follicle-stimulating hormone (FSH), IU/L
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
pituitary prolactin
Description
pituitary prolactin (PRL), mIU/L
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
total testosterone
Description
total testosterone (TT), ng/ml
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
free testosterone
Description
free testosterone (FT), pg/ml
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
Sex hormone binding globulin
Description
Sex hormone binding globulin (SHBG), nmol/L
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
Androstenedione
Description
Androstenedione (AD), ng/ml
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
dehydroepiandrosterone sulfate
Description
dehydroepiandrosterone sulfate (DHEAS), ug/dl
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
controlled attenuation parameter
Description
controlled attenuation parameter (CAP), dB/m
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
liver stiffness measurement
Description
liver stiffness measurement (LSM), kPa
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
total body fat
Description
percentage of total body fat, %
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
total body lean
Description
percentage of total body lean, %
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
total fat mass
Description
total fat mass, kg
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
total lean mass
Description
total lean mass, kg
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Title
the change in subcutaneous adipose tissue
Description
the change in subcutaneous adipose tissue (pretreatment-post-treatment) after achievement of the weight loss target
Time Frame
from randomization to the time of achievement of the weight loss target, an average of 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shen Qu, Dr
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Tenth People' Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs