Metformin in Postmenopausal Women With Metabolic Syndrome

Phase 4

• Conditions: Metabolic Syndrome
• Interventions: Drug: Placebo; Drug: Metformin

• Registration Number: NCT01342744
• Lead Sponsor: Mahidol University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-25
• Study First Submitted QC: 2011-04-26
• Study First Posted: 2011-04-27
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-14
• Last Update Posted: 2011-05-17
• Primary Completion: 2012-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo 1 tab oral twice a day
Metformin	Metformin	Metformin (850mg) 1 tab oral twice a day

Primary Outcome Measures

Name	Time	Method
Cardiovascular risk factors	6 months	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

Name	Time	Method
10-year risk of coronary heart disease	6 months	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

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkoknoi, Bangkok, Thailand