None listed
Conditions
Brief summary
This study will investigate the effect of metformin on breast tissue in well women intending to undergo reduction mammoplasty. There is an interest in the possibility that metformin could decrease breast cancer incidence or cancer related deaths. Our proposed research is to examine the effects of metformin treatment on LKB1 expression and activity, AMPK phosphorylation and CRTC2 phosphorylation and translocation, as tissue in vivo and to explore relationships between identified cellular effects with serum indicators of insulin resistance.
Interventions
one week administration of oral metformin 500mg tablet (to minimize side effects) followed by one week of oral metformin 1000mg daily then 4 weeks administration of oral metformin 1500mg daily (3 x 500mg tablets)
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
38 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Women a) who are aged between 38 and 60 years b) who are attending a breast surgeon and are scheduled to have a reduction mammoplasty c) who have provided informed consent
Exclusion criteria
1. Women with any of the following: a) Use of any systemic hormones in the last 6 months; b) serious endocrine disorder with systemic disease; c) alcohol consumption greater than 3 standard drinks per day; d) known acute or chronic liver disease; e) cardiac failure requiring medication f) known renal disease g) chronic hypoxic lung disease e) type 2 or insulin dependent diabetes mellitus or use of an oral hypoglycemic agent. 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
None listed