Metformin as Added on Therapy in Patients With Ulcerative Colitis

Tanta University

Status and phase: Enrolling; Phase 2

Conditions: Inflammatory Bowel Diseases

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT05574387

6/2022

Details and patient eligibility

About

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

Enrollment: 46 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

46 participants in 2 patient groups

Control Group

No Intervention group

Description:

This group will take mesalamine 1 g three times daily

Metformin group

Active Comparator group

Description:

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

Treatment:

Drug: Metformin