Empagliflozin in Adolescent Diabetes

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT04917692
Phase
PHASE4
Status
Withdrawn

Conditions

  • type1diabetes

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 31, 2021
Status verified
Mar 2023
Primary completion
Jun 30, 2022
Completion
Oct 31, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: empagliflozin
    empagliflozin 2.5 mg daily

Primary Outcome Measure

Interleukin 6 [ Time Frame: 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State UniversityColumbusOhio43210-

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By research site
Ohio State University· Columbus, OH

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