Metformin in Patients With Ulcerative Colitis Treated With Mesalamine

• Sponsor: Tanta University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05553704
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 37.6
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa, however, the exact underlying mechanisms of UC remain poorly understood.UC is strongly dependent on cellular immune reaction and exaggerated inflammatory response due to genetic, immune and environmental factors.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases	Drug: Metformin	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Clinical Study to Compare the Possible Efficacy of Metformin in Patients With Ulcerative Colitis Treated With Mesalamine
• Actual Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Nov 1, 2025
• Anticipated Study Completion Date: Dec 20, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Group this group will take mesalamine 1 gm three times daily for 6 months
Active Comparator: metformin group this group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily for 6 months	Drug: Metformin; metformin group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily

Outcome Measures

Primary Outcome Measures

1. The primary endpoint is the improvement in health-related quality of life (HRQL). [6 months]

   HRQL questionnaire will be assessed according to the short form-36 questionnaire. The SF-36 is an indicator of overall health status and contains 10 items. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 -100

Secondary Outcome Measures

1. The secondary endpoint is estimated by changes in serum IL-6 and IL-10 [6 months]

   The secondary endpoint is estimated by changes in serum IL-6 and IL-10

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥ 18 years

• Both males and females will be included

• Negative pregnancy test and effective contraception

Exclusion Criteria:

• •

• Breast feeding

• Significant liver and kidney function abnormalities

• Diabetic patients

• Colorectal cancer patients

• Patients with severe UC

• Patients taking rectal or systemic steroids

• Patients taking immunosuppressives or biological therapies

• Addiction to alcohol and / or drugs

• Known allergy to the studied medications

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Mansoura University	Mansoura		Egypt	35511

Sponsors and Collaborators

• Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mostafa Bahaa, Teaching Assistant, Tanta University
• ClinicalTrials.gov Identifier: NCT05553704
• Other Study ID Numbers: 3422
• First Posted: Sep 23, 2022
• Last Update Posted: Nov 4, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases; Metformin

Study Results

No Results Posted as of Nov 4, 2022