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Metformin in Postmenopausal Women With Metabolic Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Mahidol University.
Recruitment status was:  Recruiting
Information provided by:
Mahidol University Identifier:
First received: April 25, 2011
Last updated: May 14, 2011
Last verified: May 2011
The purpose of this study is to determine the effects of metformin on cardiovascular risk factors in postmenopausal women with metabolic syndrome.

Condition Intervention Phase
Metabolic Syndrome Drug: Metformin Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Metformin on Cardiovascular Risk Factors in Postmenopausal Women With Metabolic Syndrome

Resource links provided by NLM:

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Cardiovascular risk factors [ Time Frame: 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:
  • 10-year risk of coronary heart disease [ Time Frame: 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

Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin
Metformin (850mg) 1 tab oral twice a day
Drug: Metformin
Metformin(850 mg) 1tab oral twice aday
Placebo Comparator: Placebo
Placebo 1 tab oral twice a day
Drug: Placebo
Placebo 1 tab oral twice a day


Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01342744

Contact: Suchada Indhavivadhana, M.D. 0-2419-4657

Siriraj Hospital Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Suchada Indhavivadhana, M.D.    0-2419-4657   
Sponsors and Collaborators
Mahidol University
Principal Investigator: Suchada Indhavivadhana, M.D. Mahidol University
  More Information

Responsible Party: Suchada Indhavivadhana, Mahidol University Identifier: NCT01342744     History of Changes
Other Study ID Numbers: Si091/2011
Study First Received: April 25, 2011
Last Updated: May 14, 2011

Keywords provided by Mahidol University:
Cardiovascular risk factors

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 21, 2017