Metformin as Added on Therapy in Patients With Ulcerative Colitis

NCT05574387 | Recruiting Phase 2

• 1 other identifier: 6/2022
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Improvement in HRQL through changes in inflammatory bowel disease questionnaire (IBDQ) score and change in mayo scores

  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.

  6 months

Study Arms (2)

Control Group

NO INTERVENTION

This group will take mesalamine 1 g three times daily

Metformin group

ACTIVE COMPARATOR

This group will take mesalamine 1 g three times daily plus metformin 500 mg two times daily

Drug: Metformin

Interventions

Metformin DRUG

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)

Metformin group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- Breastfeeding Significant liver and kidney function abnormalities Diabetic patients Colorectal cancer patients Patients with severe UC Patients taking rectal or systemic steroids

Sponsors & Collaborators

• Tanta University: lead
• Principal Investigator Mostafa Mahmoud Bahaa El-Dien Pharmacy Practice Department- Horus University: collaborator

Study Sites (1)

Faculty of Medicine, Mansoura University

Al Mansurah, 7650001, Egypt

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Metformin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Mostafa Bahaa, PhD

CONTACT

0201025538337; mbahaa@horus.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 10, 2022
• Study Start: January 20, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 4, 2025

Record last verified: 2025-03

Locations

EG (1)