Metformin for the management of insulin resistance in overweight women at midlife.

Phase 4

Completed

• Conditions: insulin resistance; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12610000836033
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 124

Inclusion Criteria

Women:1. who are aged between 35-65 years. 2. who have a BMI >30kg/m2 and <40kg/m2 and/or a waist circumference > 88cm. 3.who have provided informed consent.

Exclusion Criteria

1. Women with any of the following: (a) Use of testosterone, or dehydroepiandosterone (DHEA) in the last 3 months, or last 7 months in the case of hormonal implants (b) known severe psychiatric illness (c) uncontrolled hypertension, Systolic blood pressure (BP) > 160, Diastolic BP > 100 (d) pregnancy and lactation (e) serious endocrine disorder with systemic disease (f) alcohol consumption greater than 3 standard drinks per day (g) known acute or chronic liver disease (bilirubin > 26, alanine transferase > 100 U/L, alkaline phosphatase > 300 U/L) (h) Type 2 diabetes mellitus (T2DM), insulin dependent diabetes mellitus or use of an oral hypoglycemic agent (i) acute / chronic renal, liver, cardiovascular disease or any other chronic major illness which would impair overall health and wellbeing 2. Women who, in the opinion of the investigator, are a poor medical or psychiatric risk for treatment in a research protocol. 3. Women who have participated in a medical or surgical research protocol in the preceding 28 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the efficacy of metformin in mitigating the development of insulin resistance (IR) and diabetes in its preclinical phase in obese (body mass index (BMI) >30 and < 40 kg/m2 and waist circumference >88cm) euglycaemic-women in midlife. The primary outcome measurewill be change in IR determined by change in the homeostasis model of assessment (HOMA-IR). [after 6 months of treatment]