Metformin as Added on Therapy in Patients With Ulcerative Colitis

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05574387
• Other study ID #: 6/2022
• Status: Recruiting
• Phase: Phase 2
• Start date: January 20, 2023
• Est. completion date: April 2027

Study information

• Verified date: February 2024
• Source: Tanta University
• Contact: Mostafa Bahaa, PhD
• Phone: 0201025538337
• Email: mbahaa[@]horus.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: April 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases

Intervention

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)

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Mansoura University	Mansoura

Sponsors (4)

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

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months