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Metformin as Added on Therapy in Patients With Ulcerative Colitis

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 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

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 g three times daily

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05574387

First Posted

October 6, 2022

Last Updated

February 7, 2023

Sponsor

Tanta University

Collaborators

Principal Investigator Sahar El-Haggar, Prof Clinical pharmacy Department- Tanta University, Principal Investigator Sahar Hegazy, Prof Clinical pharmacy Department- Tanta University, Principal Investigator Mostafa Mahmoud Bahaa El-Dien Pharmacy Practice Department- Horus University

1. Study Identification

Unique Protocol Identification Number

NCT05574387

Brief Title

Metformin as Added on Therapy in Patients With Ulcerative Colitis

Official Title

Metformin, The Biguanide Derivative, as Adjuvant Therapy in Patients With Ulcerative Colitis Treated With Mesalamine

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 20, 2023 (Actual)

Primary Completion Date

December 2026 (Anticipated)

Study Completion Date

April 2027 (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 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

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

Masking Description

double-blinded

Allocation

Randomized

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

This group will take mesalamine 1 g three times daily

Arm Title

Metformin group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

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)

Primary Outcome Measure Information:

Title

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

Description

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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mostafa Bahaa, PhD

Phone

0201025538337

mbahaa@horus.edu.eg

Facility Information:

Facility Name

Faculty of Medicine, Mansoura University

City

Mansoura

ZIP/Postal Code

7650001

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mostafa Bahaa, PhD

Phone

0201025538337

mbahaa@horus.edu.eg

12. IPD Sharing Statement

Learn more about this trial

Metformin as Added on Therapy in Patients With Ulcerative Colitis

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