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

Study Overview
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Brief Summary
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•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
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It will be conducted on 60 patients having with mild to moderate degree UC divided into two groups: Group 1 (n=30): Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid). 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 Complete blood picture (CBC). Liver functions (ALT, AST, Total and Direct Bilirubin). Kidney functions tests (Urea, serum creatinine). C-reactive protein. Fasting blood glucose. 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

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

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Empagliflozin
* Drug: conventional treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel randomized controlled
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo group<br>Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid) for 4 months. | Drug: conventional treatment<br>* conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months<br>|
| Experimental: empagliflozin group<br>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. | Drug: Empagliflozin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expression of TNFalpha | difference between the two groups in TNFalpha | 4months | 
| expression of Adenosine monophosphate kinase (9AMPK ). | difference between the two groups in Adenosine monophosphate kinase (9AMPK ) | 4months | 
| expression of Fecal calprotectin | difference between the two groups in fecal calprotectin | 4months |