Metformin in Patients With Ulcerative Colitis Treated With Mesalamine
Primary Purpose
Inflammatory Bowel Diseases
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine, Mansoura UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control Group
metformin group
Arm Description
this group will take mesalamine 1 gm three times daily for 6 months
this group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily for 6 months
Outcomes
Primary Outcome Measures
The primary endpoint is the improvement in health-related quality of life (HRQL).
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
The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha
The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha
Full Information
NCT ID
NCT05553704
First Posted
September 20, 2022
Last Updated
June 15, 2023
Sponsor
Tanta University
Collaborators
Sahar Mohamed El-Haggar clinical pharmacy department, Tanta University, Sahar Kamal Hegazi clinical pharmacy department, Tanta University, Mounir Hussein Bahgat Internal Medicine Department Mansoura University, Maha Mohamed Maher Internal Medicine Department Mansoura University
1. Study Identification
Unique Protocol Identification Number
NCT05553704
Brief Title
Metformin in Patients With Ulcerative Colitis Treated With Mesalamine
Official Title
Clinical Study to Compare the Possible Efficacy of Metformin in Patients With Ulcerative Colitis Treated With Mesalamine
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
December 20, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
Collaborators
Sahar Mohamed El-Haggar clinical pharmacy department, Tanta University, Sahar Kamal Hegazi clinical pharmacy department, Tanta University, Mounir Hussein Bahgat Internal Medicine Department Mansoura University, Maha Mohamed Maher Internal Medicine Department Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
this group will take mesalamine 1 gm three times daily for 6 months
Arm Title
metformin group
Arm Type
Active Comparator
Arm Description
this group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
metformin group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily
Primary Outcome Measure Information:
Title
The primary endpoint is the improvement in health-related quality of life (HRQL).
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha
Description
The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mostafa Bahaa
Phone
0201025538337
Email
mostafabahaamnf@gmail.com
Facility Information:
Facility Name
Faculty of Medicine, Mansoura University
City
Mansoura
ZIP/Postal Code
35511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mostafa M Bahaa, PhD
Phone
0201025538337
Email
mbahaa@horus.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Metformin in Patients With Ulcerative Colitis Treated With Mesalamine
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