Diabetic Neuropathy Peripheral
Conditions
Brief summary
The aim of the study is to investigate the possible protective effect of empagliflozin in patients with type 2 diabetes mellitus with diabetic peripheral neuropathy and not on SGLT2 inhibitors treatment.
Interventions
DRUGEmpagliflozin 25 MG
treatment
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Patients with type 2 diabetes mellitus (Hba1c 7 %- 9%). Patients receiving dipeptidyl peptidase-4 inhibitors, metformin ± basal insulin. Patients with peripheral neuropathy and not on SGLT2 inhibitor treatment. Patients aged between 18 years old to 65 years old.
Exclusion criteria
* Breastfeeding female. * Pregnant female. * Estimated Glomerular Filtration Rate less than 45 mL/minute/1.73 m2. * Patients with type 1 diabetes mellitus. * Patients with diabetic ketoacidosis. * Patients with urinary tract infections. * Dehydrated patients till normalized. * Lower limb amputation patients. * SGLT2 inhibitors hypersensitivity. * Severe hepatic patients. * Patients on neuroprotective drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the electrophysiological assessment of sensory and motor nerve conduction of the lower limb extremities. | change from baseline at three month | The electrophysiological studies will be performed using Nihon Kohden Neuropack, six-channel apparatus (Nihon Kohden, Japan) using surface electrodes, for the two studied groups. |
| Change in HbA1c % | change from baseline at three months | HbA1c % will be assayed in whole blood using an automated System (H.P.L.C model: G89051, Tosoh, USA), for the two studied groups. |
Countries
Egypt
Outcome results
None listed