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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05610956
• Other study ID #: empagliflozin in UC
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: December 1, 2022
• Est. completion date: December 1, 2026

Study information

• Verified date: November 2022
• Source: Tanta University
• Contact: youmna hamdy eldeeb, phD
• Phone: 01014860930
• Email: youmnahamdyeldeeb[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

References & Publications (15)

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Iannantuoni F, M de Marañon A, Diaz-Morales N, Falcon R, Bañuls C, Abad-Jimenez Z, Victor VM, Hernandez-Mijares A, Rovira-Llopis S. The SGLT2 Inhibitor Empagliflozin Ameliorates the Inflammatory Profile in Type 2 Diabetic Patients and Promotes an Antioxidant Response in Leukocytes. J Clin Med. 2019 Nov 1;8(11). pii: E1814. doi: 10.3390/jcm8111814. — View Citation

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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. — View Citation

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Merigo F, Brandolese A, Facchin S, Missaggia S, Bernardi P, Boschi F, D'Incà R, Savarino EV, Sbarbati A, Sturniolo GC. Glucose transporter expression in the human colon. World J Gastroenterol. 2018 Feb 21;24(7):775-793. doi: 10.3748/wjg.v24.i7.775. — View Citation

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. Review. — View Citation

Rubin DT, Huo D, Kinnucan JA, Sedrak MS, McCullom NE, Bunnag AP, Raun-Royer EP, Cohen RD, Hanauer SB, Hart J, Turner JR. Inflammation is an independent risk factor for colonic neoplasia in patients with ulcerative colitis: a case-control study. Clin Gastroenterol Hepatol. 2013 Dec;11(12):1601-8.e1-4. doi: 10.1016/j.cgh.2013.06.023. Epub 2013 Jul 17. — View Citation

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* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	expression of TNFalpha	difference between the two groups in TNFalpha	4months
Secondary	expression of Adenosine monophosphate kinase (9AMPK ).	difference between the two groups in Adenosine monophosphate kinase (9AMPK )	4months
Secondary	expression of Fecal calprotectin	difference between the two groups in fecal calprotectin	4months