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

Primary Purpose

Type 1 Diabetes Mellitus, Diabetic Ketoacidosis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
3-hydroxybutyrate
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Steno diabetes center Aarhus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

3 hours of continuously intravenous infusion of 3-hydroxybutyrate.

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

Outcomes

Primary Outcome Measures

Differences in lipolysis rate
Measured as differences in palmitate flux

Secondary Outcome Measures

Changes in protein metabolism
Measured as differences in forearm and whole body tracer kinetics
Changes in glucose kinetics
Measured by glucose tracer.
Cardiac function
Changes in cardiac output and left ventricular ejection fraction measured by echocardiography
Changes in signaling in muscle and adipose tissue
Western blot examinations of muscle and adipose tissue biopsies
Differences in circulating concentrations of 3-hydroxybutyrate, glucose, free fatty acids, insulin, glucagon and C-peptide
Blood samples

Full Information

First Posted
November 30, 2020
Last Updated
March 7, 2022
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04656236
Brief Title
Metabolic Effects of Exogenous 3-hydroxybutyrate in Patients With Type 1 Diabetes and Healthy Controls
Official Title
Metabolic Effects of Exogenous 3-hydroxybutyrate in Patients With Type 1 Diabetes and Healthy Controls
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 3-OHB related inhibition of lipolysis is impaired in patients with type 1 diabetes. Intravenous infusion of 3-OHB affects signaling pathways involved in the metabolic regulation in patients with type 1 diabetes and healthy controls. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Diabetic Ketoacidosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover design in 2 different groups, patients with type 1 diabetes and healthy controls.
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
3 hours of continuously intravenous infusion of 3-hydroxybutyrate.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
3 hours of continuously intravenous infusion of saline (NaCl).
Intervention Type
Biological
Intervention Name(s)
3-hydroxybutyrate
Intervention Description
3-hydroxybutyrate is a metabolite, produced in the human body.
Primary Outcome Measure Information:
Title
Differences in lipolysis rate
Description
Measured as differences in palmitate flux
Time Frame
After 3 hours of interventions
Secondary Outcome Measure Information:
Title
Changes in protein metabolism
Description
Measured as differences in forearm and whole body tracer kinetics
Time Frame
After 3 hours of interventions
Title
Changes in glucose kinetics
Description
Measured by glucose tracer.
Time Frame
After 3 hours of interventions
Title
Cardiac function
Description
Changes in cardiac output and left ventricular ejection fraction measured by echocardiography
Time Frame
After 2-3 hours of interventions
Title
Changes in signaling in muscle and adipose tissue
Description
Western blot examinations of muscle and adipose tissue biopsies
Time Frame
After 1,5-3 hours of interventions
Title
Differences in circulating concentrations of 3-hydroxybutyrate, glucose, free fatty acids, insulin, glucagon and C-peptide
Description
Blood samples
Time Frame
During the 3 hours intervention period

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Møller, Professor
Organizational Affiliation
Department of Endocrinology and Steno Diabetes Center Aarhus, Aarhus University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maj Bangshaab, MD
Organizational Affiliation
Steno Diabetes Center Aarhus and Aarhus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steno diabetes center Aarhus
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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

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