Metformin as Added on Therapy in Patients With Ulcerative Colitis

Phase 2

Recruiting

• Conditions: Inflammatory Bowel Diseases
• Interventions: Drug: Metformin

• Registration Number: NCT05574387
• Lead Sponsor: Tanta University

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-06
• Study First Posted: 2022-10-10
• Study Start: 2023-01-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-01
• Last Update Posted: 2025-03-04
• Primary Completion: 2026-12
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin group	Metformin	This group will take mesalamine 1 g three times daily plus metformin 500 mg two times daily

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Faculty of Medicine, Mansoura University; 🇪🇬 Mansoura, Egypt