Metformin as Added on Therapy in Patients With Ulcerative Colitis

NCT ID: NCT05574387

Last Updated: 2025-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-20

Study Completion Date

2027-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Inflammatory Bowel Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
double-blinded

Study Groups

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Control Group

This group will take mesalamine 1 g three times daily

Group Type NO_INTERVENTION

No interventions assigned to this group

Metformin group

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

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Principal Investigator Mostafa Mahmoud Bahaa El-Dien Pharmacy Practice Department- Horus University

UNKNOWN

Sponsor Role collaborator

Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mostafa Bahaa

Teaching Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine, Mansoura University

Al Mansurah, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mostafa Bahaa, PhD

Role: CONTACT

0201025538337

Facility Contacts

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Mostafa Bahaa, PhD

Role: primary

0201025538337

Other Identifiers

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6/2022

Identifier Type: -

Identifier Source: org_study_id

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