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

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University of Aarhus

Status

Completed

Conditions

Healthy

Treatments

Other: Ketone bodies
Drug: Somatropin

Study type

Interventional

Funder types

Other

Identifiers

NCT02655263
Ketone8000

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

Male

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

10 participants in 3 patient groups

Control
No Intervention group
Description:
12 hours of fasting
GH infusion
Experimental group
Description:
12 hours of fasting
Treatment:
Drug: Somatropin
GH and ketone bodies infusion
Experimental group
Description:
12 hours of fasting
Treatment:
Drug: Somatropin
Other: Ketone bodies

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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