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

Primary Purpose

Polycystic Ovary Syndrome (PCOS), Overweight, Obesity

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Metformin-GLP-1 Receptor Agonist

Metformin-Oral Contraceptive(OC)

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome (PCOS) focused on measuring Polycystic Ovary Syndrome (PCOS), Overweight, Obesity, GLP-1 Agonist, Oral contraceptives (OCs), Metformin, Reproductive Disorders, Cardiovascular risk factor, Lipid Metabolism

Eligibility Criteria

14 Years - 50 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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 14 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.

Sites / Locations

The Second Affiliated Hospital, Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Metformin-GLP-1 Receptor Agonist

Metformin-Oral Contraceptive(OC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Assessment of Reproductive Functions

Concentration of LH was measured in U/L.

Secondary Outcome Measures

Basic Vital Signs

Weight and height will be combined to report BMI in kg/m^2.

Assessment of Glucose Metabolism

Fasting glucose was measured in mmol/L.

Assessment of Lipid Metabolism

Controlled attenuation parameters (CAP) measurement.

Assessment of Cardiovascular Risks

Carotid artery intima-media thickness (CIMT).

Full Information

NCT ID

NCT03151005

First Posted

April 28, 2017

Last Updated

December 3, 2018

Sponsor

Xinqiao Hospital of Chongqing

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03151005

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2017 (Actual)

Primary Completion Date

December 3, 2018 (Anticipated)

Study Completion Date

December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xinqiao Hospital of Chongqing

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

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

Polycystic Ovary Syndrome (PCOS), Overweight, Obesity

Keywords

Polycystic Ovary Syndrome (PCOS), Overweight, Obesity, GLP-1 Agonist, Oral contraceptives (OCs), Metformin, Reproductive Disorders, Cardiovascular risk factor, Lipid Metabolism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Metformin-GLP-1 Receptor Agonist

Arm Type

Experimental

Arm Description

Arm Title

Metformin-Oral Contraceptive(OC)

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Metformin-GLP-1 Receptor Agonist

Other Intervention Name(s)

Metformin-exenatide/liraglutide Therapy

Intervention Description

metformin oral with exenatide/liraglutide subcutaneous injection.

Intervention Type

Drug

Intervention Name(s)

Metformin-Oral Contraceptive(OC)

Other Intervention Name(s)

Metformin, Diane 35

Intervention Description

metformin with Diane 35 oral intake.

Primary Outcome Measure Information:

Title

Assessment of Reproductive Functions

Description

Concentration of LH was measured in U/L.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Basic Vital Signs

Description

Weight and height will be combined to report BMI in kg/m^2.

Time Frame

4 weeks

Title

Assessment of Glucose Metabolism

Description

Fasting glucose was measured in mmol/L.

Time Frame

12 weeks

Title

Assessment of Lipid Metabolism

Description

Controlled attenuation parameters (CAP) measurement.

Time Frame

12 weeks

Title

Assessment of Cardiovascular Risks

Description

Carotid artery intima-media thickness (CIMT).

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 14 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xing Li, PhD

Phone

13062313858

xiahcaihong@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Min Long, MD

Phone

023-68763255

longmin_casper@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Min long, MD

Organizational Affiliation

Department of Endocrinology, Xinqiao Hospital,Third Military Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Second Affiliated Hospital, Third Military Medical University

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400037

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Min Long, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

http://bethesda.org

Learn more about this trial

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

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