Overview

The Effect of Dapagliflozin on Ultrafiltration Among Peritoneal Dialysis Patients

Status:
Recruiting
Trial end date:
2021-09-01
Target enrollment:
0
Participant gender:
All
Summary
Patients with average or high average peritoneal glucose transport status be included in the study as mentioned in the inclusion and exclusion criteria. The change in peritoneal glucose transport will be evaluated before and after one month treatment with 10 mg of Dapagliflozin. Peritoneal Equilibration Test (PET) test for patients before and after Dapagliflozin use and volume status of patients as measured by ultrafiltration from peritoneal dialysis exchanges. The aim of the trial is to determine whether dapagliflozin can decrease glucose absorption from peritoneal fluid and reduce plasma glucose absorption from the PD fluid and thus improve ultrafiltration with a reduction in intraperitoneal glucose exposure
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
An-Najah National University
Treatments:
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Dapagliflozin
Criteria
Inclusion Criteria:

- The research targets patients on peritoneal dialysis with average and high transport
status documented by Peritoneal Equilibrium Transport Test (PET test) in Najah
National University Hospital.

Exclusion Criteria:

1. Patients less than 18 years

2. An episode of Peritonitis in less than three months

3. History of recurrent hypoglycemia ( more than two episodes during one month prior to
enrollment in the study)

4. Liver disease: Hepatic impairment aspartate transaminase [AST] or alanine transaminase
[ALT] >3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of
enrolment)

5. Any allergic reaction to dapagliflozin

6. Type I DM

7. Pregnancy or women who are breast-feeding

8. Symptomatic hypotension or a mean arterial pressure (MAP) less than 60 mmHg

9. MI, unstable angina, stroke, or transient ischemic attack (TIA) within 12 weeks before
enrolment

10. Active malignancy requiring treatment at the time of visit -