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Substrate Metabolism, Growth Hormone Signaling (GH), and Insulin Sensitivity During GH and Ketone Bodies Infusion

NCT ID: NCT02655263

Last Updated: 2017-11-01

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-10-31

Brief Summary

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Background: Humans naturally produce ketone bodies under daily living conditions. The main ketone bodies are two functioning acids, beta-hydroxybutyric acid (3-OHB) and acetoacetate, and the pH-neutral, but odorous, acetone. In the fed state, level of 3-OHB is suppressed to an almost unmeasurable level while, in the fasted state, it rises to 0.1-0.5 millimoles (mM). Main regulation of ketone synthesis is the abundance of sugars and resulting adaptations in insulin secretion. Thus, ketone bodies are formed when sugar is not readily available and insulin is suppressed. This picture is, to a certain degree, seen in acute inflammatory states and, indeed, during starvation, where level of 3-OHB increases to 5-8 mM.

Hypothesis:

1. Ketone bodies changes the insulin sensitivity and substrate metabolism in human subjects
2. Ketone bodies changes the GH signaling in muscle and adipose tissue

Aim: The investigators wish to provide knowledge on changes in metabolites and shift in signaling pathways and insulin sensitivity during GH infusion and concomitant ketone bodies infusion among healthy subjects.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

12 hours of fasting

Group Type NO_INTERVENTION

No interventions assigned to this group

GH infusion

12 hours of fasting

Group Type EXPERIMENTAL

Somatropin

Intervention Type DRUG

Somatropin infusion (Genotropin®)

GH and ketone bodies infusion

12 hours of fasting

Group Type EXPERIMENTAL

Somatropin

Intervention Type DRUG

Somatropin infusion (Genotropin®)

Ketone bodies

Intervention Type OTHER

ketone bodies infusion

Interventions

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Somatropin

Somatropin infusion (Genotropin®)

Intervention Type DRUG

Ketone bodies

ketone bodies infusion

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy men
* written consent
* body mass index (BMI) 18.5 - 25
* age 20-50 years

Exclusion Criteria

* any kind of disease
* regular medication
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens Otto L. Jørgensen, Professor

Role: PRINCIPAL_INVESTIGATOR

Aarhus University / Aarhus University Hospital

Jens Otto L. Jørgensen, Professor

Role: STUDY_DIRECTOR

Aarhus University / Aarhus University Hospital

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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Hogild ML, Hjelholt AJ, Hansen J, Pedersen SB, Moller N, Wojtaszewski JFP, Johannsen M, Jessen N, Jorgensen JOL. Ketone Body Infusion Abrogates Growth Hormone-Induced Lipolysis and Insulin Resistance. J Clin Endocrinol Metab. 2023 Feb 15;108(3):653-664. doi: 10.1210/clinem/dgac595.

Reference Type DERIVED
PMID: 36240323 (View on PubMed)

Other Identifiers

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Ketone8000

Identifier Type: -

Identifier Source: org_study_id