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Metformin in Postmenopausal Women With Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT01342744
Recruitment Status : Unknown
Verified May 2011 by Mahidol University.
Recruitment status was:  Recruiting
First Posted : April 27, 2011
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Drug: Metformin Drug: Placebo Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : April 2011
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : March 2012


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Suchada Indhavivadhana, Mahidol University
ClinicalTrials.gov Identifier: NCT01342744     History of Changes
Other Study ID Numbers: Si091/2011
First Posted: April 27, 2011    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: May 2011

Keywords provided by Mahidol University:
Cardiovascular risk factors

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