Metformin as Added on Therapy in Patients With Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metformin.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Diseases. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Metformin, The Biguanide Derivative, as Adjuvant Therapy in Patients With Ulcerative Colitis Treated With Mesalamine
Overview
Ulcerative colitis (UC) is a chronic inflammatory bowel disease that is marked by increased intestinal motility and bloody diarrhea. The clinical value of existing therapeutic strategies of UC, including glucocorticoids, anti-tumor necrosis factor α (TNF-α), mesalamine, and thiopurines is still limited. Therefore, the discovery of new therapeutic approaches is essential to improve the effectiveness of the treatment.Adenosine monophosphate (AMP)-activated protein kinase (AMPK) is a conserved fuel-sensing enzyme that plays an important role in the regulation of cellular metabolism where it increases glucose and fatty acids uptake and activates the oxidation process to improve the cellular energy utilization
Interventions
- Drug Metformin
Metformin is an antidiabetic biguanide drug that acts by promoting glucose uptake and utilization in the liver.Recent studies proved that metformin could reduce colonic inflammation by AMPK-mediated inhibition of p38 mitogen-activated protein kinase (MAPK)
Primary outcome measures
- Improvement in HRQL through changes in inflammatory bowel disease questionnaire (IBDQ) score and change in mayo scores [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
\- Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception Mild and moderate UC patients diagnosed and confirmed by the endoscope
Exclusion criteria
\- Breastfeeding Significant liver and kidney function abnormalities Diabetic patients Colorectal cancer patients Patients with severe UC Patients taking rectal or systemic steroids
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Medicine, Mansoura University — Al Mansurah
Identifiers
NCT: NCT05574387 · 6/2022