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

Sponsor
Mostafa Bahaa
Study ID
NCT05986136
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Inflammatory Bowel Diseases

Eligibility Criteria

Sex
ALL
Age
18 Months - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Mesalamine — DRUG
    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
  • Dapagliflozin 10mg Tab — DRUG
    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

Study Details

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.

Key Dates

Start date
Aug 20, 2023
Status verified
Mar 2026
Primary completion
Aug 20, 2027
Completion
Jul 20, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

The primary endpoint is the change in mayo score [ Time Frame: 6 months ]

Central Contacts

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