Metformin in Postmenopausal Women With Metabolic Syndrome

Effects of Metformin on Cardiovascular Risk Factors in Postmenopausal Women With Metabolic Syndrome

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01342744

Enrollment

Registered

2011-04-27

Start date

2011-04-30

Completion date

2012-03-31

Last updated

2011-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

Cardiovascular risk factors

Brief summary

The purpose of this study is to determine the effects of metformin on cardiovascular risk factors in postmenopausal women with metabolic syndrome.

Interventions

DRUGMetformin

Metformin(850 mg) 1tab oral twice aday

DRUGPlacebo

Placebo 1 tab oral twice a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Cardiovascular risk factors	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

Secondary

Measure	Time frame	Description
10-year risk of coronary heart disease	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

Countries

Thailand

Contacts

Primary ContactSuchada Indhavivadhana, M.D.

sisto@mahidol.ac.th0-2419-4657

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026