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

University of Aarhus

Status: Completed

Conditions: Healthy

Treatments: Behavioral: 12 hour fast; Drug: GH hormone infusion; Behavioral: 42 hour fast

Study type: Interventional

Funder types: Other

Identifiers

NCT01209429

M-20100150

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 estimated patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy lean men
• age >18

Exclusion criteria

• metabolic disturbances
• alcohol drug abuse
• malign disease: current or previous

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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10 participants in 4 patient groups, including a placebo group

42 hour fast/GH infusion

Experimental group

Treatment:

Behavioral: 42 hour fast

Drug: GH hormone infusion

42 hour fast/Placebo infusion

Experimental group

Treatment:

Behavioral: 42 hour fast

12 hour fast/GH infusion

Experimental group

Treatment:

Drug: GH hormone infusion

Behavioral: 12 hour fast

12 hour fast/Placebo infusion

Placebo Comparator group

Treatment:

Behavioral: 12 hour fast