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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01342744
First Posted: April 27, 2011
Last Update Posted: May 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mahidol University
April 25, 2011
April 27, 2011
May 17, 2011
April 2011
March 2012   (Final data collection date for primary outcome measure)
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
Cardiovascular risk factors [ Time Frame: 6 months ]
To compare the cardiovascular risk factors, including blood pressue, FBS, HOMA-IR, 75-g OGTT, lipid profile, hs-CRP, neck circumference and waist circumference, between metformin and plcebo at 6 months
Complete list of historical versions of study NCT01342744 on ClinicalTrials.gov Archive Site
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
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 EGAT score, between metformin group and placebo at 6 months
Not Provided
Not Provided
 
Metformin in Postmenopausal Women With Metabolic Syndrome
Effects of Metformin on Cardiovascular Risk Factors in Postmenopausal Women With Metabolic Syndrome
The purpose of this study is to determine the effects of metformin on cardiovascular risk factors in postmenopausal women with metabolic syndrome.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Metabolic Syndrome
  • Drug: Metformin
    Metformin(850 mg) 1tab oral twice aday
  • Drug: Placebo
    Placebo 1 tab oral twice a day
  • Experimental: Metformin
    Metformin (850mg) 1 tab oral twice a day
    Intervention: Drug: Metformin
  • Placebo Comparator: Placebo
    Placebo 1 tab oral twice a day
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
March 2012
March 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
45 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT01342744
Si091/2011
Yes
Not Provided
Not Provided
Suchada Indhavivadhana, Mahidol University
Mahidol University
Not Provided
Principal Investigator: Suchada Indhavivadhana, M.D. Mahidol University
Mahidol University
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP