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

Официальное название

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

Обзор

•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.

Подробное описание

* 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

Вмешательства

• Препарат 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.
• Препарат conventional treatment
  conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months

Первичные конечные точки

• clinical improvement of patients of mild to moderate UC using using the Montreal classification of severity of ulcerative colitis. [Срок оценки: 4months]

Вторичные конечные точки (3)

• expression of TNFalpha [Срок оценки: 4months]
• expression of Adenosine monophosphate activated protein kinase (AMPK ). [Срок оценки: 4months]
• expression of Fecal calprotectin [Срок оценки: 4months]

Критерии участия

Критерии включения

•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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Gastroenterology and Endoscopy Unit, Internal Medicine Department, Tanta University Hospit — Tanta

Публикации

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• Jess T, Frisch M, Simonsen J. Trends in overall and cause-specific mortality among patients with inflammatory bowel disease from 1982 to 2010. Clin Gastroenterol Hepatol. 2013 Jan;11(1):43-8. doi: 10.1016/j.cgh.2012.09.026. Epub 2012 Sep 27. PMID 23022699
• Regueiro M, Greer JB, Szigethy E. Etiology and Treatment of Pain and Psychosocial Issues in Patients With Inflammatory Bowel Diseases. Gastroenterology. 2017 Feb;152(2):430-439.e4. doi: 10.1053/j.gastro.2016.10.036. Epub 2016 Nov 2. PMID 27816599
• MacDermott RP, Sanderson IR, Reinecker HC. The central role of chemokines (chemotactic cytokines) in the immunopathogenesis of ulcerative colitis and Crohn's disease. Inflamm Bowel Dis. 1998 Feb;4(1):54-67. doi: 10.1097/00054725-199802000-00009. PMID 9552229

Идентификаторы

NCT: NCT05610956 · empagliflozin in UC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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