NCT05610956

Evaluate the Possible Efficacy and Safety of Empagliflozin in Patient With Ulcerative Colitis

Clinical Study to Evaluate the Possible Efficacy and Safety of Empagliflozin in Patients With Ulcerative Colitis

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Empagliflozin	Patients will receive empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day)and conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months.
DRUG	conventional treatment	conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2022-11-09
• Last updated: 2025-07-16

Locations

1 site across 1 country: Egypt