None listed
Conditions
Brief summary
This project aims to assess the safety of Metformin and how well it works in patients with active Ulcerative Colitis. Metformin is approved in Australia to treat Type 2 Diabetes and has been used for over 50 years. In addition its effect on blood glucose metformin has more recently been shown to have anti-inflammatory effects, which are important in the activity and severity of ulcerative colitis. Metformin may have a therapeutic benefit in ulcerative colitis via this anti-inflammatory effect.
Interventions
Metformin 500mg oral twice daily for six weeks. Adherence will be assessed by pill counts.
Sponsors
Gregory Moore
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Adults age 18-60 years Confirmed diagnosis of ulcerative colitis for greater than 3 months Mild to moderately active UC (defined by a Mayo score of 4-10) despite a minimum of 4 weeks of therapy with at least 3g daily of oral 5-ASA compound Endoscopic sub score of greater than or equal to 1
Exclusion criteria
Renal impairment (eGFR < 60) Lactic acidosis Sensitivity or previous intolerance to metformin Pregnant or breast feeding Evidence of infectious colitis on basis of stool culture Poorly controlled T2DM (HbA1c > 8.0%) Inability to provide informed consent Contraindication to flexible sigmoidoscopy New York Heart Association Class III or IV heart failure Active malignancy other than non-melanoma skin cancer in the last 5 years. Taking interacting drugs: vit K antagonists; cimetidine; nifedipine; beta blockers; alcohol; iodinated contrast materials Liver disease
Outcome results
None listed