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

Sponsor

Mostafa Bahaa (Other)

Overall Status

Recruiting

CT.gov ID

NCT05986136

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Aug 20, 2023

Anticipated Primary Completion Date :

Aug 20, 2024

Anticipated Study Completion Date :

Jul 20, 2028

Arms and Interventions

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

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

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

Primary Outcome Measures

The primary endpoint is the change in mayo score [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

Criteria

Ages Eligible for Study:

18 Months to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Mansoura University	Mansoura		Egypt	7650001

Sponsors and Collaborators

Mostafa Bahaa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mostafa Bahaa, Teaching assisstant, Tanta University

ClinicalTrials.gov Identifier:

NCT05986136

Other Study ID Numbers:

Tanta 1234

First Posted:

Aug 14, 2023

Last Update Posted:

Aug 14, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Intestinal Diseases

Inflammatory Bowel Diseases

Dapagliflozin

Mesalamine

Study Results

No Results Posted as of Aug 14, 2023