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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655263
• Other study ID #: Ketone8000
• Status: Completed
• Phase: N/A
• First received: January 7, 2016
• Last updated: October 31, 2017
• Start date: January 2016
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Insulin Resistance

Intervention

Drug:
• Somatropin
Somatropin infusion (Genotropin®)

Other:
• Ketone bodies
ketone bodies infusion

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Glucose metabolism	Change in glucose metabolism assessed by tracer kinetics on every study day.	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.
Secondary	Insulin and growth hormone signaling, expressed as CHANGE in messenger ribonucleic acid (mRNA) expression of target genes in muscle- and fat-tissue.	Change in mRNA expression of target genes using Polymerase Chain Reaction (PCR).	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	Investigation of the balance in the autonomic nervous system	Heart rate variability (the study of beat-to-beat fluctuations in heart rate).	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.