Metformin as Added on Therapy in Patients With Ulcerative Colitis

Sponsor

Tanta University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05574387

Collaborator

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

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

double-blinded

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Apr 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Group This group will take mesalamine 1 g three times daily
Active Comparator: Metformin group This group will take mesalamine 1 g three times daily plus metformin 500 mg two times daily	Drug: Metformin 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)

Arm

Intervention/Treatment

No Intervention: Control Group

This group will take mesalamine 1 g three times daily

Active Comparator: Metformin group

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

Drug: Metformin

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)

Outcome Measures

Primary Outcome Measures

Improvement in HRQL through changes in inflammatory bowel disease questionnaire (IBDQ) score and change in mayo scores [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tanta University
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

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:

NCT05574387

Other Study ID Numbers:

6/2022

First Posted:

Oct 10, 2022

Last Update Posted:

Nov 15, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colitis

Colitis, Ulcerative

Inflammatory Bowel Diseases

Metformin

Study Results

No Results Posted as of Nov 15, 2022