Importance of the GH/IGF-1 Axis for Human Substrate and Energy Metabolism During Calorie Restriction

This study will investigate whether growth hormone is modulated by the enzyme SIRT1 and by that is stimulating lipolysis on expense of IGF-I production. This is done in 10 healthy men on calorie restriction on 4 study days with fat and skeletal muscle biopsies.

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Key information

Conditions

Healthy Behavior Fasting Feeding Behavior

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Aarhus, Norrebrogade

Aarhus, 8000, Denmark

About this study

It has been shown that calorie restriction enhances the length of life in yeast, worms, fish and rodent. Whether this elongation of life due to calorie restriction can be applied to humans is not known. However, it is a fact that calorie restriction will decrease the risk of developing metabolic disturbances such as diabetes, hypertension and atherosclerosis.

On the molecular level the specific relations are not fully understood. This study will investigate the possible connection between SITR1 and the relation to the GH/IGF-I axis and STAT5b in healthy men. The participant will fast 42 and 12 hours respectively, and have GH or placebo infusions. The design is a classical 2x2 design and will be randomized.

Knowledge of the interactions between calorie restriction, SIRT1, STAT5b and the GH/IGF-I axis will apply important information about the relations between aging, energy metabolism and metabolic disturbances.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

healthy lean men
age >18

Exclusion criteria

metabolic disturbances
alcohol drug abuse
malign disease: current or previous

Treatment and study plan

GH hormone infusion

Drug

Norditropin 30 ng/kg/min

Other names: Norditropin, Genotropin

42 hour fast

Behavioral

The participant will be fasting 42 hours prior to the start of the study day, drinking water is allowed

Other names: No other name

12 hour fast

Behavioral

12 hour fast will be used as a control scenario to 42 hour fast

Other names: No other name

Primary outcomes

Description of intracellular pathways to clarify the interplay between calorie restriction, SIRT1, STATb5, and the GH/IGF-I axis

Time frame: 6 hour study days

All study days consists of 3 hour basic periods and 3 hours hyperinsulinemic, euglycemic clamp.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Sep 27, 2010
Registry last updated: Sep 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed