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

University of Aarhus

Status: Completed

Conditions: Type 1 Diabetes Mellitus; Diabetic Ketoacidosis

Treatments: Biological: 3-hydroxybutyrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04656236

1-10-72-251-20

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Patients with type 1 diabetes:

Inclusion Criteria:

• Type 1 diabetes diagnosis
• C-peptide negative
• 19 < BMI < 26
• written consent

Exclusion Criteria:

• Severe comorbidity
• Regular medication apart from insulin (except over-the-counter medicines)
• Use of long acting insulin analogues, that work > 24 hours, e.g. Tresiba
• PI finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other).

Healthy control subjects:

Inclusion Criteria:

• 19 < BMI < 26
• written consent

Exclusion Criteria:

• Chronic disease
• Regular medication (except over-the-counter medicines)
• PI finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

3 hours of continuously intravenous infusion of 3-hydroxybutyrate.

Treatment:

Biological: 3-hydroxybutyrate

Control

Placebo Comparator group

Description:

3 hours of continuously intravenous infusion of saline (NaCl).

Treatment:

Biological: 3-hydroxybutyrate