Metformin in Postmenopausal Women With Metabolic Syndrome

NCT ID: NCT01342744

Last Updated: 2011-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-03-31

Brief Summary

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

Detailed Description

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Metformin

Metformin (850mg) 1 tab oral twice a day

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Metformin(850 mg) 1tab oral twice aday

Placebo

Placebo 1 tab oral twice a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 1 tab oral twice a day

Interventions

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Metformin

Metformin(850 mg) 1tab oral twice aday

Intervention Type DRUG

Placebo

Placebo 1 tab oral twice a day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Mahidol University

Principal Investigators

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Suchada Indhavivadhana, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Suchada Indhavivadhana, M.D.

Role: CONTACT

0-2419-4657

Facility Contacts

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Suchada Indhavivadhana, M.D.

Role: primary

0-2419-4657

Other Identifiers

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Si091/2011

Identifier Type: -

Identifier Source: org_study_id

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