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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

April 25, 2011
May 14, 2011
April 2011
March 2012   (final data collection date for primary outcome measure)
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
Cardiovascular risk factors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 ] [ 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
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 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Metabolic Syndrome
  • Drug: Metformin
    Metformin(850 mg) 1tab oral twice aday
    Other Name: Metformin
  • Drug: Placebo
    Placebo 1 tab oral twice a day
    Other Name: Placebo
  • 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.
 
Recruiting
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
Female
45 Years to 60 Years
Yes
Contact: Suchada Indhavivadhana, M.D. 0-2419-4657 sisto@mahidol.ac.th
Thailand
 
NCT01342744
Si091/2011
Yes
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