Activation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease

Official Summary

The inflammatory bowel diseases (IBD) are described as complex, recurrent inflammatory conditions which are manifested as Crohn's disease (CD) and ulcerative colitis (UC). The common symptoms of IBD include debilitating/severe diarrhea, abdominal pain, weight loss, and chronic fatigue; events that may culminate in life-threatening complications. The pathogenesis of IBD has been characterized as complex/multi-factorial that includes disruption of intestinal epithelial barrier with consequent translocation of commensal microbial products as the prime event that instigates severe immune responses and intestinal inflammation.

Eligibility Requirements

• Minimum Age: 18 Months
• Maximum Age: 60 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE
• Enrollment: 50 participants

Study Arms

• control group (ACTIVE_COMPARATOR)
  Control group ( Mesalamine group, n =30 ) who will receive 1 g mesalamine three times daily for 6 months
• Dapagliflozin group (ACTIVE_COMPARATOR)
  Patients will receive 1 g mesalamine three times daily plus dapagliflozin 10 mg once daily for 6 months

Interventions

• DRUG: Mesalamine — Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a medication used to treat ulcerative colitis. It is usually used to induce or maintain remission of mildly to moderately active ulcerative colitis
• DRUG: Dapagliflozin 10mg Tab — Dapagliflozin has emerged as a selective SGLT2 inhibitor for the management of type-2 diabetes mellitus with minimal risk of hypoglycemia and it exerts diuretic-like actions and lowering of blood pressure, thereby, reducing the risk of hospitalization in type-2 diabetic patients with co-existing heart failure

Primary Outcomes

• The primary endpoint is the change in mayo score (6 months)

Eligibility Criteria

Inclusion Criteria:

* Age ≥ 18 years
* Both male and female will be
* Mild and moderate UC patients diagnosed and confirmed by endoscope

Exclusion Criteria:

* Breast feeding
* Significant liver and kidney function abnormalities
* 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 dapagliflozin

Trial Locations

• Faculty of Medicine, Mansoura University, Al Mansurah, Egypt

Contact Information

• Mostafa Bahaa, PhD — CONTACT
  Phone: 0201025538337
  Email: mbahaa@horus.edu.eg

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