Metformin in Postmenopausal Women With Metabolic Syndrome
Effects of Metformin on Cardiovascular Risk Factors in Postmenopausal Women With Metabolic Syndrome
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to determine the effects of metformin on cardiovascular risk factors in postmenopausal women with metabolic syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 25, 2011
CompletedFirst Posted
Study publicly available on registry
April 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedMay 17, 2011
May 1, 2011
11 months
April 25, 2011
May 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiovascular risk factors
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
6 months
Secondary Outcomes (1)
10-year risk of coronary heart disease
6 months
Study Arms (2)
Metformin
EXPERIMENTALMetformin (850mg) 1 tab oral twice a day
Placebo
PLACEBO COMPARATORPlacebo 1 tab oral twice a day
Interventions
Eligibility Criteria
You may qualify if:
- Postmenopausal women aged 45-60 years with metabolic syndrome according to The American Heart Association and The National Heart, Lung, and Blood Institute
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Siriraj Hospital
Bangkoknoi, Bangkok, 10700, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suchada Indhavivadhana, M.D.
Mahidol University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 25, 2011
First Posted
April 27, 2011
Study Start
April 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
May 17, 2011
Record last verified: 2011-05