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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Inflammatory Bowel Diseases | Drug: Mesalamine Drug: Dapagliflozin 10mg Tab | Phase 2 Phase 3 |
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 |
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
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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
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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 |
- 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
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Ages Eligible for Study: | 18 Months to 60 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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
Contact: Mostafa Bahaa, PhD | 0201025538337 | mbahaa@horus.edu.eg |
Egypt | |
Faculty of Medicine, Mansoura University | Recruiting |
Mansoura, Egypt, 7650001 | |
Contact: Mostafa Bahaa, PhD 0201025538337 mbahaa@horus.edu.eg |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |