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Metformin in Postmenopausal Women With Metabolic Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Mahidol University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01342744
First received: April 25, 2011
Last updated: May 14, 2011
Last verified: May 2011
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Cardiovascular risk factors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Other Name: Metformin
Placebo Comparator: Placebo
Placebo 1 tab oral twice a day
 Drug: Placebo
Placebo 1 tab oral twice a day
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   45 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342744

Contacts
Contact: Suchada Indhavivadhana, M.D. 0-2419-4657 sisto@mahidol.ac.th

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

No publications provided

Responsible Party: Suchada Indhavivadhana, Mahidol University
ClinicalTrials.gov Identifier: NCT01342744     History of Changes
Other Study ID Numbers: Si091/2011
Study First Received: April 25, 2011
Last Updated: May 14, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Cardiovascular risk factors

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013