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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-03-01

Brief Summary

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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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Detailed Description

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Conditions

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Type 1 Diabetes Mellitus Diabetic Ketoacidosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover design in 2 different groups, patients with type 1 diabetes and healthy controls.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

3 hours of continuously intravenous infusion of 3-hydroxybutyrate.

Group Type EXPERIMENTAL

3-hydroxybutyrate

Intervention Type BIOLOGICAL

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

Control

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

Group Type PLACEBO_COMPARATOR

3-hydroxybutyrate

Intervention Type BIOLOGICAL

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

Interventions

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3-hydroxybutyrate

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

* 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:

* 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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes