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

NCT ID: NCT05986136

Last Updated: 2025-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-20

Study Completion Date

2028-07-20

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammatory Bowel Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
double-blinded

Study Groups

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control group

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

Group Type ACTIVE_COMPARATOR

Mesalamine

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Mesalamine

Intervention Type 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

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Months

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mostafa Bahaa

OTHER

Sponsor Role lead

Responsible Party

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Mostafa Bahaa

Teaching assisstant

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Faculty of Medicine, Mansoura University

Al Mansurah, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mostafa Bahaa, PhD

Role: CONTACT

0201025538337

Facility Contacts

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Mostafa Bahaa, PhD

Role: primary

0201025538337

Other Identifiers

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Tanta 1234

Identifier Type: -

Identifier Source: org_study_id

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