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

August 2, 2022 updated by: Zhang Manna, Shanghai 10th People's Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the change in visceral adipose tissue
Time Frame: 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
until achievement of the weight loss target,an average of 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
menstrual frequency
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
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
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
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
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
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
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
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
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
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
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
fasting insulin (FINS), mU/L
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
postprandial insulin
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
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
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
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
Time Frame: 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)
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
alanine aminotransferase
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
alanine aminotransferase (ALT), U/L
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
aspartate aminotransferase
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
aspartate aminotransferase (AST), U/L
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Total cholesterol
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Total cholesterol (TC), mmol/L
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Triglycerides
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
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
Time Frame: 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
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
low-density lipoprotein cholesterol
Time Frame: 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
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Creatinine
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Creatinine (Cr), umol/L
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
serum uric acid
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
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
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
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
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
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
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
pituitary prolactin (PRL), mIU/L
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
total testosterone
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
total testosterone (TT), ng/ml
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
free testosterone
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
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
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
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
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Androstenedione (AD), ng/ml
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
dehydroepiandrosterone sulfate
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
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
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
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
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
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
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
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
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
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
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
total fat mass, kg
from randomization to the time of achievement of the weight loss target, an average of 12 weeks
total lean mass
Time Frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
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
Time Frame: 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
from randomization to the time of achievement of the weight loss target, an average of 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai 10th People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Shen Qu, Dr, Shanghai 10th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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