NCT04656236

Brief 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. 1.3-OHB related inhibition of lipolysis is impaired in patients with type 1 diabetes.
  2. 2.Intravenous infusion of 3-OHB affects signaling pathways involved in the metabolic regulation in patients with type 1 diabetes and healthy controls.
  3. 3.3-OHB infusion improves cardiac function in patients with type 1 diabetes and healthy controls.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

March 8, 2022

Status Verified

December 1, 2021

Enrollment Period

1.2 years

First QC Date

November 30, 2020

Last Update Submit

March 7, 2022

Conditions

Type 1 Diabetes MellitusDiabetic Ketoacidosis

Outcome Measures

Primary Outcomes (1)

  • Differences in lipolysis rate

    Measured as differences in palmitate flux

    After 3 hours of interventions

Secondary Outcomes (5)

  • Changes in protein metabolism

    After 3 hours of interventions

  • Changes in glucose kinetics

    After 3 hours of interventions

  • Cardiac function

    After 2-3 hours of interventions

  • Changes in signaling in muscle and adipose tissue

    After 1,5-3 hours of interventions

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

    During the 3 hours intervention period

Study Arms (2)

Intervention

EXPERIMENTAL

3 hours of continuously intravenous infusion of 3-hydroxybutyrate.

Biological: 3-hydroxybutyrate

Control

PLACEBO COMPARATOR

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

Biological: 3-hydroxybutyrate

Interventions

3-hydroxybutyrateBIOLOGICAL

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

ControlIntervention

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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:
  • \< BMI \< 26
  • written consent
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno diabetes center Aarhus

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Bangshaab M, Svart MV, Rittig N, Pedersen MGB, Voigt J, Jessen N, Moller N. Metabolic effects of 3-hydroxybutyrate infusion in individuals with type 1 diabetes compared with healthy control participants: a randomised crossover trial showing intact feedback suppression of lipolysis. Diabetologia. 2025 Jul;68(7):1390-1402. doi: 10.1007/s00125-025-06423-5. Epub 2025 Apr 10.

    PMID: 40210728DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetic Ketoacidosis

Interventions

3-Hydroxybutyric Acid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesKetosisAcidosisAcid-Base ImbalanceDiabetes Complications

Intervention Hierarchy (Ancestors)

HydroxybutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsKetone BodiesKetonesFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Niels Møller, Professor

    Department of Endocrinology and Steno Diabetes Center Aarhus, Aarhus University Hospital

    STUDY DIRECTOR

  • Maj Bangshaab, MD

    Steno Diabetes Center Aarhus and Aarhus University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Crossover design in 2 different groups, patients with type 1 diabetes and healthy controls.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 7, 2020

Study Start

January 1, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

March 8, 2022

Record last verified: 2021-12

Locations

DK(1)