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

Tanta University

Status and phase: Enrolling; Early Phase 1

Conditions: Ulcerative Colitis

Treatments: Drug: conventional treatment; Drug: Empagliflozin

Study type: Interventional

Funder types: Other

Identifiers

NCT05610956

empagliflozin in UC

Details and patient eligibility

About

•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.

Full 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

7. 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

placebo group

Placebo Comparator group

Description:

Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid) for 4 months.

Treatment:

Drug: conventional treatment

empagliflozin group

Experimental group

Description:

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.

Treatment:

Drug: Empagliflozin