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Completed

NCT Number: NCT04656236

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

3-hydroxybutyrate

Biological

3-hydroxybutyrate is a metabolite, produced in the human body.

Primary outcomes

  1. Differences in lipolysis rate

    Time frame: After 3 hours of interventions

    Measured as differences in palmitate flux

Secondary outcomes

  1. Changes in protein metabolism

    Time frame: After 3 hours of interventions

    Measured as differences in forearm and whole body tracer kinetics

  2. Changes in glucose kinetics

    Time frame: After 3 hours of interventions

    Measured by glucose tracer.

  3. Cardiac function

    Time frame: After 2-3 hours of interventions

    Changes in cardiac output and left ventricular ejection fraction measured by echocardiography

  4. Changes in signaling in muscle and adipose tissue

    Time frame: After 1,5-3 hours of interventions

    Western blot examinations of muscle and adipose tissue biopsies

  5. Differences in circulating concentrations of 3-hydroxybutyrate, glucose, free fatty acids, insulin, glucagon and C-peptide

    Time frame: During the 3 hours intervention period

    Blood samples

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 7, 2020
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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