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

Early Phase 1

Not yet recruiting

• Conditions: Ulcerative Colitis
• Interventions: Drug: conventional treatment; Drug: Empagliflozin

• Registration Number: NCT05610956
• Lead Sponsor: Tanta University

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 kinase (9AMPK). 3. Fecal calprotectin. All patients will be assessed at baseline and after 4 months of therapy for all parameters

Study Timeline

• Study First Submitted: 2022-10-31
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-03
• Study First Posted: 2022-11-09
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14
• Study Start: 2022-12-01
• Primary Completion: 2023-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

•Patients with mild to moderate UC are diagnosed by history, clinical signs according to the Montreal classification of severity of ulcerative colitis and( Endoscopy, and biopsy) to establish the chronicity of inflammation and to exclude other causes of colitis.

Exclusion Criteria

• Other inflammatory bowel diseases (CD).
• History of serious hypersensitivity to empagliflozin or any component of the formulation.
• Patients on dialysis.
• Severe renal impairment (eGFR <20 ml/minute/1.73m2) .
• Chronic urinary tract infection.
• Chronic genital infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	conventional treatment	Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid) for 4 months.
empagliflozin group	Empagliflozin	Patients will receive conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid) and empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day)for 4months.

Primary Outcome Measures

Name	Time	Method
clinical improvement of patients of mild to moderate UC using using the Montreal classification of severity of ulcerative colitis.	4months	difference between the two groups in (number of stool per day+prescence of fever +present of systemic toxicity+hemoglibin +ESR)

Secondary Outcome Measures

Name	Time	Method
expression of Adenosine monophosphate kinase (9AMPK ).	4months	difference between the two groups in Adenosine monophosphate kinase (9AMPK )
expression of TNFalpha	4months	difference between the two groups in TNFalpha
expression of Fecal calprotectin	4months	difference between the two groups in fecal calprotectin