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

NCT05986136 | Recruiting Phase 2

• 1 other identifier: Tanta 1234
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the change in mayo score

  The Mayo score is one of the most commonly used disease activity indices in placebo-controlled trials in UC. In its complete form, it is composed of four parts: rectal bleeding, stool frequency, physician assessment, and endoscopy appearance

  6 months

Study Arms (2)

control group

ACTIVE COMPARATOR

Control group ( Mesalamine group, n =30 ) who will receive 1 g mesalamine three times daily for 6 months

Drug: Mesalamine

Dapagliflozin group

ACTIVE COMPARATOR

Patients will receive 1 g mesalamine three times daily plus dapagliflozin 10 mg once daily for 6 months

Drug: Mesalamine; Drug: Dapagliflozin 10mg Tab

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 group; control group

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

Dapagliflozin group

Eligibility Criteria

• Age: 18 Months - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mostafa Bahaa: lead

Study Sites (1)

Faculty of Medicine, Mansoura University

Al Mansurah, 7650001, Egypt

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Mesalamine; dapagliflozin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Central Study Contacts

Mostafa Bahaa, PhD

CONTACT

0201025538337; mbahaa@horus.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Teaching assisstant

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 14, 2023
• Study Start: August 20, 2023
• Primary Completion (Estimated): August 20, 2027
• Study Completion (Estimated): July 20, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

EG (1)