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Metformin in Postmenopausal Women With Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status

Unknown status

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Metformin

Placebo

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Cardiovascular risk factors

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Postmenopausal women aged 45-60 years with metabolic syndrome according to The American Heart Association and The National Heart, Lung, and Blood Institute

Exclusion Criteria:

Previous cardiovascular diseases
Contraindicated to metformin: serum creatinine >1.4 mg/dL, liver disease, alcoholism, congestive heart failure, chronic hypoxic lung disease, prior history of lactic acidosis
Previous administration of metformin, other hypoglycemic drugs, lipid-lowering drugs, sex steroids, antiplatelet drugs within 3 months before enrollment
Fasting blood sugar ≥ 200 mg/dL or HbA1c >8%
Serum triglyceride ≥500 mg/dL
Abnormal EKG

Sites / Locations

Siriraj HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Metformin

Placebo

Arm Description

Metformin (850mg) 1 tab oral twice a day

Placebo 1 tab oral twice a day

Outcomes

Primary Outcome Measures

Cardiovascular risk factors

To compare the cardiovascular risk factors, including blood pressue, fasting blood sugar (FBS), Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR), 75-g oral glucose tolerance test (75-g OGTT), lipid profile, high sensitivity C-reactive protein(hs-CRP), neck circumference and waist circumference, between metformin and plcebo at 6 months

Secondary Outcome Measures

10-year risk of coronary heart disease

To compare 10-year risk of coronary heart disease, which is calculated from RAMA- Electricity Generating Authority of Thailand (RAMA-EGAT) score, between metformin group and placebo at 6 months

Full Information

NCT ID

NCT01342744

First Posted

April 25, 2011

Last Updated

May 14, 2011

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT01342744

Brief Title

Metformin in Postmenopausal Women With Metabolic Syndrome

Official Title

Effects of Metformin on Cardiovascular Risk Factors in Postmenopausal Women With Metabolic Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Unknown status

Study Start Date

April 2011 (undefined)

Primary Completion Date

March 2012 (Anticipated)

Study Completion Date

March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine the effects of metformin on cardiovascular risk factors in postmenopausal women with metabolic syndrome.

6. Conditions and Keywords

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

Metabolic Syndrome

Keywords

Cardiovascular risk factors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Metformin

Arm Type

Experimental

Arm Description

Metformin (850mg) 1 tab oral twice a day

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo 1 tab oral twice a day

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

Metformin(850 mg) 1tab oral twice aday

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo 1 tab oral twice a day

Primary Outcome Measure Information:

Title

Cardiovascular risk factors

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

10-year risk of coronary heart disease

Description

To compare 10-year risk of coronary heart disease, which is calculated from RAMA- Electricity Generating Authority of Thailand (RAMA-EGAT) score, between metformin group and placebo at 6 months

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Postmenopausal women aged 45-60 years with metabolic syndrome according to The American Heart Association and The National Heart, Lung, and Blood Institute Exclusion Criteria: Previous cardiovascular diseases Contraindicated to metformin: serum creatinine >1.4 mg/dL, liver disease, alcoholism, congestive heart failure, chronic hypoxic lung disease, prior history of lactic acidosis Previous administration of metformin, other hypoglycemic drugs, lipid-lowering drugs, sex steroids, antiplatelet drugs within 3 months before enrollment Fasting blood sugar ≥ 200 mg/dL or HbA1c >8% Serum triglyceride ≥500 mg/dL Abnormal EKG

Central Contact Person:

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

Suchada Indhavivadhana, M.D.

Phone

0-2419-4657

sisto@mahidol.ac.th

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suchada Indhavivadhana, M.D.

Organizational Affiliation

Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Siriraj Hospital

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Suchada Indhavivadhana, M.D.

Phone

0-2419-4657

sisto@mahidol.ac.th

12. IPD Sharing Statement

Learn more about this trial

Metformin in Postmenopausal Women With Metabolic Syndrome

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