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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
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
April 25, 2011
Last Updated
May 14, 2011
Sponsor
Mahidol University
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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
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
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
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
Email
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
Email
sisto@mahidol.ac.th

12. IPD Sharing Statement

Learn more about this trial

Metformin in Postmenopausal Women With Metabolic Syndrome

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