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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209429
• Other study ID #: M-20100150
• Status: Completed
• Phase: N/A
• First received: September 24, 2010
• Last updated: September 12, 2011
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• healthy lean men

• age >18

Exclusion Criteria:

• metabolic disturbances

• alcohol drug abuse

• malign disease: current or previous

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GH hormone infusion
Norditropin 30 ng/kg/min

Behavioral:
• 42 hour fast
The participant will be fasting 42 hours prior to the start of the study day, drinking water is allowed
• 12 hour fast
12 hour fast will be used as a control scenario to 42 hour fast

Locations

Country	Name	City	State
Denmark	University Hospital of Aarhus, Norrebrogade	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	Description of intracellular pathways to clarify the interplay between calorie restriction, SIRT1, STATb5, and the GH/IGF-I axis	All study days consists of 3 hour basic periods and 3 hours hyperinsulinemic, euglycemic clamp.	6 hour study days	No