Metformin in Postmenopausal Women With Metabolic Syndrome
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to determine the effects of metformin on cardiovascular risk factors in postmenopausal women with metabolic syndrome. |
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Condition | Metabolic Syndrome |
Intervention | Drug: Metformin Drug: Placebo |
Phase | Phase 4 |
Sponsor | Mahidol University |
Responsible Party | Mahidol University |
ClinicalTrials.gov Identifier | NCT01342744 |
First Received | April 25, 2011 |
Last Updated | May 14, 2011 |
Last verified | May 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | April 25, 2011 |
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Last Updated Date | May 14, 2011 |
Start Date | April 2011 |
Estimated Primary Completion Date | March 2012 |
Current 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 |
Current 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 |
Descriptive Information[ + expand ][ + ]
Brief Title | Metformin in Postmenopausal Women With Metabolic Syndrome |
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Official Title | Effects of Metformin on Cardiovascular Risk Factors in Postmenopausal Women With Metabolic Syndrome |
Brief Summary | The purpose of this study is to determine the effects of metformin on cardiovascular risk factors in postmenopausal women with metabolic syndrome. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Metabolic Syndrome |
Intervention | Drug: Metformin Metformin(850 mg) 1tab oral twice aday Other Names: MetforminDrug: Placebo Placebo 1 tab oral twice a day Other Names: Placebo |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 40 |
Estimated Completion Date | March 2012 |
Estimated Primary Completion Date | March 2012 |
Eligibility 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 |
Gender | Female |
Ages | 45 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Contact: Suchada Indhavivadhana, M.D. 0-2419-4657 sisto@mahidol.ac.th |
Location Countries | Thailand |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01342744 |
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Other Study ID Numbers | Si091/2011 |
Has Data Monitoring Committee | Yes |
Information Provided By | Mahidol University |
Study Sponsor | Mahidol University |
Collaborators | Not Provided |
Investigators | Principal Investigator: Suchada Indhavivadhana, M.D. Mahidol University |
Verification Date | May 2011 |
Locations[ + expand ][ + ]
Siriraj Hospital | Bangkoknoi, Bangkok, Thailand, 10700 Contact: Suchada Indhavivadhana, M.D. | 0-2419-4657 | sisto@mahidol.ac.thRecruiting |
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