NCT02655263

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable healthy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

1.8 years

First QC Date

January 7, 2016

Last Update Submit

October 31, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Insulin and growth hormone signaling, expressed as CHANGE in phosphorylation of intracellular target proteins in muscle- and fat-tissue.

    Change in phosphorylation of target proteins using Western Blotting (WB)

    Muscle and fat biopsies obtained at t1= 9.00 am (60 min) and t2=12.30 am (270 min) on each study day after 0, 4 and 8 weeks (interval of 4 weeks between each of the three study days

Secondary Outcomes (3)

  • Glucose metabolism

    Change in glucose metabolism using glucose tracer from t=0 min - 360 min on each study day after 0, 4 and 8 weeks (interval of 4 weeks between each of the three study days.

  • Insulin and growth hormone signaling, expressed as CHANGE in messenger ribonucleic acid (mRNA) expression of target genes in muscle- and fat-tissue.

    Muscle and fat biopsies obtained at t1= 9.00 am (60 min) and t2=12.30 am (270 min) on each study day after 0, 4 and 8 weeks (interval of 4 weeks between each of the three study days.

  • Investigation of the balance in the autonomic nervous system

    Measurement of heart rate variability at t1=10.30 am(150 min) and 12.30 am (270 min) on each study day after 0, 4 and 8 weeks (interval of 4 weeks between each of the three study days.

Study Arms (3)

Control

NO INTERVENTION

12 hours of fasting

GH infusion

EXPERIMENTAL

12 hours of fasting

Drug: Somatropin

GH and ketone bodies infusion

EXPERIMENTAL

12 hours of fasting

Drug: SomatropinOther: Ketone bodies

Interventions

SomatropinDRUG

Somatropin infusion (Genotropin®)

GH and ketone bodies infusionGH infusion
Ketone bodiesOTHER

ketone bodies infusion

GH and ketone bodies infusion

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • any kind of disease
  • regular medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 36240323DERIVED

MeSH Terms

Interventions

Human Growth HormoneKetone Bodies

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsKetonesOrganic Chemicals

Study Officials

  • Jens Otto L. Jørgensen, Professor

    Aarhus University / Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • Jens Otto L. Jørgensen, Professor

    Aarhus University / Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 14, 2016

Study Start

January 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

November 1, 2017

Record last verified: 2017-10

Locations

DK(1)