Empagliflozin in Adolescent Diabetes - Trial NCT04917692

Timeline & Enrollment

Primary Outcome

Interleukin 6,Glomerular filtration rate,Endothelial function,Number of episodes of diabetic ketoacidosis per patient

Summary

Empagliflozin, an inhibitor of the sodium glucose co-transporter 2 (SGLT2), reduces
 post-prandial glucose levels in adults with both type 2 and type 1 diabetes and importantly
 reduces both cardiovascular and renal complications in type 2 diabetes. In adults with type 1
 diabetes empagliflozin improves endothelial function and vascular stiffness when used in
 conjunction with insulin. There is clear evidence that complications in type 1 diabetes have
 their origins during adolescents thus to reduce diabetic complications with adjunctive
 therapy, this age group must be studied. These studies will need to focus on the effects of
 these adjunctive agents on functional biomarkers for development of complications. This study
 is designed to develop pilot and feasibility data for a large scale trial of low dose
 empagliflozin, 2.5 mg daily, on biomarkers for the development of cardiovascular and renal
 complications in adolescents between 12 and 18 years of age. The investigators will
 specifically study the effects of 8 weeks of empagliflozin on:
 
 1. Pre-and post-prandial inflammatory markers using high carbohydrate and high fat meals.
 Inflammatory markers to be measured include interleukin-6 (IL-6), tissue necrosing
 factor α (TNF-α), complement component C3 concentrations and skin advanced glycosylation
 endproducts (AGE).
 
 2. Pre-and post-prandial vascular function including forearm vascular resistance,
 endothelial function and pulse wave velocity.
 
 3. Microalbuminuria and pre- and post-prandial glomerular hyperfiltration, tubular injury
 and renal inflammation.
 
 The investigators will, also, measure more traditional risk markers including blood pressure,
 hemoglobin A1c, and lipids. Eligible participants will have had diabetes for at least 1 year
 and not have other chronic medical illnesses or diabetes complications. Because of the risk
 of diabetic ketoacidosis (DKA) subjects must have a hemoglobin A1c level less than 9% and
 have no history of recurrent DKA or known insulin omission. This will be the first pilot
 study designed to explore primary endpoints regarding cardiovascular and renal disease rather
 than glucose control with empagliflozin therapy in adolescents with type 1 diabetes.

ICD-10 Classifications