Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT05610956
Status:
RECRUITING
Last Update Posted:
2025-07-16
First Post:
2022-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate the Possible Efficacy and Safety of Empagliflozin in Patient With Ulcerative Colitis
Sponsor:
Tanta University
Organization:
Study Overview
Official Title:
Clinical Study to Evaluate the Possible Efficacy and Safety of Empagliflozin in Patients With Ulcerative Colitis
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
•This study will be a randomized, controlled, parallel study. .To demonstrate the efficacy of empagliflozin and clinical improvement in patients of mild to moderate UC using the Montreal classification of severity of ulcerative colitis.
Detailed Description:
* It will be conducted on 60 patients having with mild to moderate degree UC divided into two groups:
1. Group 1 (n=30): Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid).
2. Group 2 (n=30): Patients will receive conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid) and empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day).
* The patient will be selected from the Gastroenterology and Endoscopy Unit, Internal Medicine.
. All patients will be subjected to the following:
* Complete history taking.
* Colonoscopy with intubation of the ileum and biopsies of affected and unaffected areas should be obtained to confirm the diagnosis of UC.
* Blood sample collection to assess:
A) Routine Laboratory tests
1. Complete blood picture (CBC).
2. Liver functions (ALT, AST, Total and Direct Bilirubin).
3. Kidney functions tests (Urea, serum creatinine).
4. C-reactive protein.
5. Fasting blood glucose.
6. Urine analysis. B) Specific Laboratory tests
1\. Tumor necrosis factor alpha (TNF-α). 2. Adenosine monophosphate activate protein kinase (AMPK). 3. Fecal calprotectin. All patients will be assessed at baseline and after 4 months of therapy for all parameters
1. Group 1 (n=30): Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid).
2. Group 2 (n=30): Patients will receive conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid) and empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day).
* The patient will be selected from the Gastroenterology and Endoscopy Unit, Internal Medicine.
. All patients will be subjected to the following:
* Complete history taking.
* Colonoscopy with intubation of the ileum and biopsies of affected and unaffected areas should be obtained to confirm the diagnosis of UC.
* Blood sample collection to assess:
A) Routine Laboratory tests
1. Complete blood picture (CBC).
2. Liver functions (ALT, AST, Total and Direct Bilirubin).
3. Kidney functions tests (Urea, serum creatinine).
4. C-reactive protein.
5. Fasting blood glucose.
6. Urine analysis. B) Specific Laboratory tests
1\. Tumor necrosis factor alpha (TNF-α). 2. Adenosine monophosphate activate protein kinase (AMPK). 3. Fecal calprotectin. All patients will be assessed at baseline and after 4 months of therapy for all parameters
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: