Metformin in Postmenopausal Women With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01342744
• Other study ID #: Si091/2011
• Status: Recruiting
• Phase: Phase 4
• First received: April 25, 2011
• Last updated: May 14, 2011
• Start date: April 2011
• Est. completion date: March 2012

Study information

• Verified date: May 2011
• Source: Mahidol University
• Contact: Suchada Indhavivadhana, M.D.
• Phone: 0-2419-4657
• Email: sisto[@]mahidol.ac.th
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Metformin
Metformin(850 mg) 1tab oral twice aday
• Placebo
Placebo 1 tab oral twice a day

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months	No
Secondary	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	6 months	No