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.
ConditionMetabolic Syndrome
InterventionDrug: Metformin
Drug: Placebo
PhasePhase 4
SponsorMahidol University
Responsible PartyMahidol University
ClinicalTrials.gov IdentifierNCT01342744
First ReceivedApril 25, 2011
Last UpdatedMay 14, 2011
Last verifiedMay 2011

Tracking Information[ + expand ][ + ]

First Received DateApril 25, 2011
Last Updated DateMay 14, 2011
Start DateApril 2011
Estimated Primary Completion DateMarch 2012
Current Primary Outcome MeasuresCardiovascular 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 Measures10-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 TitleMetformin in Postmenopausal Women With Metabolic Syndrome
Official TitleEffects 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 DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
ConditionMetabolic Syndrome
InterventionDrug: 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)
  • Experimental: Metformin
    Metformin (850mg) 1 tab oral twice a day
  • Placebo Comparator: Placebo
    Placebo 1 tab oral twice a day

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment40
Estimated Completion DateMarch 2012
Estimated Primary Completion DateMarch 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
GenderFemale
Ages45 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsContact: Suchada Indhavivadhana, M.D.
0-2419-4657
sisto@mahidol.ac.th
Location CountriesThailand

Administrative Information[ + expand ][ + ]

NCT Number NCT01342744
Other Study ID NumbersSi091/2011
Has Data Monitoring CommitteeYes
Information Provided ByMahidol University
Study SponsorMahidol University
CollaboratorsNot Provided
Investigators Principal Investigator: Suchada Indhavivadhana, M.D. Mahidol University
Verification DateMay 2011

Locations[ + expand ][ + ]

Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Suchada Indhavivadhana, M.D. | 0-2419-4657 | sisto@mahidol.ac.th
Recruiting