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

November 9, 2022 updated by: Youmna Hamdy, Tanta University

Clinical Study to Evaluate the Possible Efficacy and Safety of Empagliflozin in Patients 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Sahar mohamed Elhaggar
  • Phone Number: 01008838807

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo group
Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid) for 4 months.
Drug: conventional treatment
conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months
EXPERIMENTAL: empagliflozin group
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
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.

What is the study measuring?

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2022

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2026

Study Registration Dates

First Submitted

October 31, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (ACTUAL)

November 9, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • empagliflozin in UC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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