Metformin as Added on Therapy in Patients With Ulcerative Colitis

NCT05574387 · tracked via the Priya Life Science Egypt tracker

Sponsor

Tanta University

Phase

Phase 2

Started

2023-01-20

Last updated

2025-03-04

Condition(s) studied

Inflammatory Bowel Diseases

Investigational drug(s) / intervention(s)

Metformin →

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)

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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

Primary outcome measure(s)

Improvement in HRQL through changes in inflammatory bowel disease questionnaire (IBDQ) score and change in mayo scores — 6 months
The IBDQ includes 32 questions, The questions are grouped into four categories: bowel symptoms (B), systemic symptoms (S), emotional function (E), and social function (SF). Response options are consistently presented as seven-point scales, scores range from 32-224.

Trial sites (1)

Facility	City	Region	Status
Faculty of Medicine, Mansoura University	Al Mansurah	Egypt	Recruiting

On this site

📄 Glucophage (metformin) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05574387 on ClinicalTrials.gov ↗ ← All trials in Egypt