Metformin in Postmenopausal Women With Metabolic Syndrome

Mahidol University

Status and phase: Unknown; Phase 4

Conditions: Metabolic Syndrome

Treatments: Drug: Metformin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01342744

Si091/2011

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Metformin

Experimental group

Description:

Metformin (850mg) 1 tab oral twice a day

Treatment:

Drug: Metformin

Placebo

Placebo Comparator group

Description:

Placebo 1 tab oral twice a day

Treatment:

Drug: Placebo