The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS

November 7, 2023 updated by: Long Min,MD, Xinqiao Hospital of Chongqing

Randomized Clinical Trial to Evaluate The Effect of Metformin-GLP-1 Receptor Agonist Versus Oral Contraceptive (OC) Therapy on Reproductive Disorders and Cardiovascular Risks in Overweight Polycystic Ovarian Syndrome (PCOS) Patients

Polycystic ovary syndrome (PCOS) is a health problem that affects one in 10 women of childbearing age, which is usually characterized by hormonal imbalance and metabolism problems such as hyperandrogenism and obesity. Diane 35 pills are classified as oral contraceptives, which effectively reduces circulating androgens and are treatment for hyperandrogenism caused androgenic skin symptoms and irregular menstrual cycles. GLP-1 Receptor Agonist(e.g. exenatide, liraglutide) have the effects of lowering blood sugar and weight control by inhibiting of gastric emptying and reducing food intake. This study aims to evaluate the effect of metformin-GLP-1 Receptor agonist combination versus metformin-Diane-35 combination treatment on lipid metabolism and cardiovascular risks in overweight polycystic ovarian syndrome (PCOS) patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Groups:

Experimental treatment: Metformin-GLP-1 Receptor Agonist Therapy.

Regular treatment: Metformin-Oral Contraceptive(OC) Therapy.

Time Point:

Initial treatment;

Post-treatment (4w);

Post-treatment (8w);

Post-treatment (12w);

Assess reproductive functions and cardiovascular risk factors.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • 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 Contact

Study Contact Backup

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400037
        • The Second Affiliated Hospital, Third Military Medical University

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

Ages Eligible for Study

14 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of PCOS according to the Rotterdam criteria based on the presence of two of three criteria: oligomenorrhoea, clinical or biochemical hyperandrogenism and polycystic ovaries on ultrasound after exclusion of other endocrine causes of hyperandrogenism.
  • Participants had no concurrent illness and were not on any prescription or over-the-counter medication that was likely to affect insulin sensitivity or lipids for the preceding 12 weeks.
  • Participants were advised not to change physical activity or dietary habits during the study period. All subjects were overweight/obese [body mass index (BMI) >=24 kg/m2 or waistline>=85cm ].
  • All subjects had normal thyroid-stimulating hormone and prolactin levels.

Exclusion Criteria:

  • smoking, alcohol use, or having taken medication within 2 months of the study that is known to affect reproductive or metabolic functions.
  • age below 18 yr or over 50 yr.
  • postmenopausal.
  • uncontrolled hypertension (blood pressure >=160/100 mm Hg).
  • preexisting OPs or GLP-1 agonists supplementation
  • alcohol intake greater than 20 g/d, or pregnancy.
  • signs of liver or renal failure or active liver disease (ALT > 2.5× the upper limit of normal values).
  • PLT<60*10^9/L,Hb<100g/L, smoking, alcohol use.
  • The patient that cannot complete the intervention or have other conditions that is not appropriate to enter the group, such as patients who are taking glucocorticoid steroids or malignant tumor treatment, etc.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin-GLP-1 Receptor Agonist
Metformin-GLP-1 Receptor Agonist Therapy: metformin 0.5 g/time by mouth, 3 times per day, with 5 ug exenatide subcutaneous injection twice per day, for 4 weeks, then change to 10ug exenatide subcutaneous injection twice per day for 8 weeks; or metformin 0.5 g/time by mouth, 3 times per day, with 0.6mg liraglutide subcutaneous injection once per day, for 1 weeks, then change to 1.2-1.8 mg liraglutide subcutaneous injection according to patient's blood glucose condition, twice per day for 8 weeks.
Drug: Metformin-GLP-1 Receptor Agonist
metformin oral with exenatide/liraglutide subcutaneous injection.
Other Names:
  • Metformin-exenatide/liraglutide Therapy
Active Comparator: Metformin-Oral Contraceptive(OC)
Metformin-Oral Contraceptive(OC) Therapy: metformin 0.5 g/ time by mouth, 3 times per day, with Diane 35(OC) 1 piece per day by mouth, for 12 weeks.
Drug: Metformin-Oral Contraceptive(OC)
metformin with Diane 35 oral intake.
Other Names:
  • Metformin, Diane 35

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Reproductive Functions
Time Frame: 12 weeks
Concentration of LH was measured in mIU/ml.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Basic Vital Signs
Time Frame: 12 weeks
Weight and height will be combined to report BMI in kg/m^2.
12 weeks
Assessment of Liver Function
Time Frame: 12 weeks
Alanine transaminase was measured in IU/L.
12 weeks
Assessment of Blood Pressure
Time Frame: 12 weeks
Systolic blood pressure was measured in mmHg.
12 weeks
Assessment of Reproductive Function
Time Frame: 12 weeks
Changes in testosterone levels were measured
12 weeks

Collaborators and Investigators

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

Sponsor

Xinqiao Hospital of Chongqing

Collaborators

University of Messina
Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Investigators

  • Principal Investigator: Min long, MD, Department of Endocrinology, Xinqiao Hospital,Third Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 1, 2017

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

April 23, 2021

Study Registration Dates

First Submitted

April 28, 2017

First Submitted That Met QC Criteria

May 9, 2017

First Posted (Actual)

May 12, 2017

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xinqiao Endocrinology

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Data will be avaliable within 6 months of study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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