The effects of metformin on the LKB1/AMP-activated protein kinase (AMPK) pathway in breast tissue, a pilot study

Phase 4

• Conditions: breast cancer; Cancer - Breast

• Registration Number: ACTRN12610000219088
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in LKB1 expression and activity. LKB1 messenger ribonucleic acid (mRNA) expression will be measured by real-time polymerase chain reaction (PCR) and Western Blot. LKB1 activity will be measured with a specific kinase assay (Merck)[4 weeks after dose of 1500mg metformin reached (starting dose is 1 week of 500mg daily)];AMPK phosphorylation and cyclic adenosine monophosphate response element-binding (CREB)-regulated transcription coactivator (CRTC2) phosphorylation and translocation.<br>Total and phospho-AMPK will be determined by Western Blot analysis.<br>Total and phospho-CTRC2 will be determined by Western Blot analysis.<br>Immunochemistry will be conducted to ascertain the subcellular localization of the CTRC2[4 weeks after dose of 1500mg metformin reached (starting dose is 1 week of 500mg daily)];Aromatase expression in breast tissue. this will be determined by qRT-PCR[4 weeks after dose of 1500mg metformin reached (starting dose is 1 week of 500mg daily)]

Secondary Outcome Measures

Name	Time	Method
no secondary outcomes[no secondary outcomes]