Overview

This trial is active, not recruiting.

Condition healthy
Treatments somatropin, ketone bodies
Sponsor University of Aarhus
Start date January 2016
End date December 2017
Trial size 10 participants
Trial identifier NCT02655263, Ketone8000

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. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose basic science
Arm
(No Intervention)
12 hours of fasting
(Experimental)
12 hours of fasting
somatropin
Somatropin infusion (Genotropin®)
(Experimental)
12 hours of fasting
somatropin
Somatropin infusion (Genotropin®)
ketone bodies
ketone bodies infusion

Primary Outcomes

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

Measure
Glucose metabolism
time frame: 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.
time frame: 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
time frame: 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.

Eligibility Criteria

Male participants from 20 years up to 50 years old.

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

Additional Information

Official title Substrate Metabolism, Growth Hormone Signaling (GH), and Insulin Sensitivity During GH and Ketone Bodies Infusion
Principal investigator Jens Otto L. Jørgensen, Professor
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Aarhus.