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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

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

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

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

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

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

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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