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NCT Number: NCT05610956

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

•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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Gastroenterology and Endoscopy Unit, Internal Medicine Department, Tanta University Hospital.

Tanta, Egypt

Location status: Recruiting

Location contact

Mohamed El Sarhan, Lecturer

CONTACT

+20 100 193 0950

About this study

  • 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
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Empagliflozin

Drug

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

Drug

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

Primary outcomes

  1. clinical improvement of patients of mild to moderate UC using using the Montreal classification of severity of ulcerative colitis.

    Time frame: 4months

    difference between the two groups in (number of stool per day+prescence of fever +present of systemic toxicity+hemoglibin +ESR)

Secondary outcomes

  1. expression of TNFalpha

    Time frame: 4months

    difference between the two groups in TNFalpha

  2. expression of Adenosine monophosphate activated protein kinase (AMPK ).

    Time frame: 4months

    difference between the two groups in Adenosine monophosphate activated protein kinase (AMPK )

  3. expression of Fecal calprotectin

    Time frame: 4months

    difference between the two groups in fecal calprotectin

Study contacts

Contact information is provided by the study sponsor or research team.

Sahar M Elhaggar

CONTACT

01008838807

youmna H eldeeb, phD

CONTACT

[email protected]

01014860930

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 9, 2022
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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