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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000836033

Enrollment

100

Registered

2010-10-06

Start date

2011-05-31

Completion date

2012-08-22

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Brief summary* Abdominal weight gain and insulin resistance (IR) significantly increase the risk of some age related conditions in midlife women, namely cardiovascular disease, dementia and breast cancer. The aim of early intervention in individuals with abdominal obesity and IR when they are still euglycaemic is to prevent progression to type 2 diabetes mellitus and the development of other co-morbidities. We hypothesise that treatment of obese midlife euglycemic women with metformin will result in improved insulin sensitivity (assessed by homeostasis model of assessment (HOMA-IR) and increase in sex hormone binding globulin (SHBG)), weight loss, improved lipid parameters and an increase in adiponectin levels.

Interventions

metformin hydrochloride, 850mg twice daily for 6 months, oral tablet

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

35 Years to 65 Years

Healthy volunteers

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.

Outcome results