Ulcerative Colitis
Conditions
Brief 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.
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 activate protein kinase (AMPK). 3. Fecal calprotectin. All patients will be assessed at baseline and after 4 months of therapy for all parameters
Interventions
DRUGEmpagliflozin
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.
DRUGconventional treatment
conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid)for 4 months
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double blinded study
Intervention model description
parallel randomized controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical improvement of patients of mild to moderate UC using using the Montreal classification of severity of ulcerative colitis. | 4months | difference between the two groups in (number of stool per day+prescence of fever +present of systemic toxicity+hemoglibin +ESR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| expression of TNFalpha | 4months | difference between the two groups in TNFalpha |
| expression of Adenosine monophosphate activated protein kinase (AMPK ). | 4months | difference between the two groups in Adenosine monophosphate activated protein kinase (AMPK ) |
| expression of Fecal calprotectin | 4months | difference between the two groups in fecal calprotectin |
Countries
Egypt
Contacts
Primary Contactyoumna H eldeeb, phD
Backup ContactSahar M Elhaggar
Outcome results
None listed