drugset / Trial / NCT04656236

Metabolic Effects of Exogenous 3-hydroxybutyrate in Patients With Type 1 Diabetes and Healthy Controls

NCT04656236 ↗

RandomizedCrossoverSingle-blindBasic science

Summary

The main objective of this clinical trial is to study the metabolic effects of intravenous infusion of the ketone body, 3-hydroxybutyrate (3-OHB), in patients with type 1 diabetes and healthy control subjects. Moreover, the investigators plan to examine regulatory mechanisms of 3-OHB that may be related to diabetic ketoacidosis. The hypotheses are: 1. 3-OHB related inhibition of lipolysis is impaired in patients with type 1 diabetes. 2. Intravenous infusion of 3-OHB affects signaling pathways involved in the metabolic regulation in patients with type 1 diabetes and healthy controls. 3. 3-OHB infusion improves cardiac function in patients with type 1 diabetes and healthy controls. The effects of 3-OHB will be investigated by isotopic tracers examinations, fat and muscle biopsies and blood samples. To evaluate effects on cardiac function echocardiography will be performed.

Timeline

Start
2021-01-01
Primary completion
2022-03-01
Completion
2022-03-01

Outcome

Met primary endpoint

paper The infusion effectively suppressed the lipolytic rates by more than 50% (p<0.001) PMID 40210728 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject 3-hydroxybutyrate Unknown — Intravenous