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

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ClinicalTrials.gov Identifier: NCT05986136
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : September 6, 2023
Sponsor:
Information provided by (Responsible Party):
Mostafa Bahaa, Tanta University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Drug: Mesalamine Drug: Dapagliflozin 10mg Tab Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: double-blinded
Primary Purpose: Treatment
Official Title: Activation of Autophagy and Suppression of Apoptosis by Dapagliflozin Attenuates Inflammatory Bowel Disease
Actual Study Start Date : August 20, 2023
Estimated Primary Completion Date : August 20, 2024
Estimated Study Completion Date : July 20, 2028

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. The primary endpoint is the change in mayo score [ Time Frame: 6 months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Months to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05986136


Contacts
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Contact: Mostafa Bahaa, PhD 0201025538337 mbahaa@horus.edu.eg

Locations
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Egypt
Faculty of Medicine, Mansoura University Recruiting
Mansoura, Egypt, 7650001
Contact: Mostafa Bahaa, PhD    0201025538337    mbahaa@horus.edu.eg   
Sponsors and Collaborators
Mostafa Bahaa
More Information
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Responsible Party: Mostafa Bahaa, Teaching assisstant, Tanta University
ClinicalTrials.gov Identifier: NCT05986136    
Other Study ID Numbers: Tanta 1234
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: September 6, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Dapagliflozin
Mesalamine
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
 Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents