Metformin in Patients With Ulcerative Colitis Treated With Mesalamine

Tanta University

Status and phase: Enrolling; Phase 2

Conditions: Inflammatory Bowel Diseases

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT05553704

3422 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Control Group

No Intervention group

Description:

this group will take mesalamine 1 gm three times daily for 6 months

metformin group

Active Comparator group

Description:

this group will take mesalamine 1 gm three times daily plus metformin 500 mg two times daily for 6 months

Treatment:

Drug: Metformin