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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: GH hormone infusion; Behavioral: 42 hour fast; Behavioral: 12 hour fast	Not Applicable

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	10 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Single (Participant)
Primary Purpose:	Basic Science
Official Title:	Importance of the GH/IGF-1 Axis for Human Substrate and Energy Metabolism During Calorie Restriction
Study Start Date :	September 2010
Actual Primary Completion Date :	September 2011
Actual Study Completion Date :	September 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 42 hour fast/GH infusion	Drug: GH hormone infusion; Norditropin 30 ng/kg/min; Other Names: Norditropin; Genotropin Behavioral: 42 hour fast; The participant will be fasting 42 hours prior to the start of the study day, drinking water is allowed; Other Name: No other name
Experimental: 42 hour fast/Placebo infusion	Behavioral: 42 hour fast; The participant will be fasting 42 hours prior to the start of the study day, drinking water is allowed; Other Name: No other name
Experimental: 12 hour fast/GH infusion	Drug: GH hormone infusion; Norditropin 30 ng/kg/min; Other Names: Norditropin; Genotropin Behavioral: 12 hour fast; 12 hour fast will be used as a control scenario to 42 hour fast; Other Name: No other name
Placebo Comparator: 12 hour fast/Placebo infusion	Behavioral: 12 hour fast; 12 hour fast will be used as a control scenario to 42 hour fast; Other Name: No other name

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• healthy lean men
• age >18

Exclusion Criteria:

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Denmark
University Hospital of Aarhus, Norrebrogade
Aarhus, Denmark, 8000

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator:	Jens Otto L Jørgensen, Professor	University Hospital of Aarhus

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nellemann B, Vendelbo MH, Nielsen TS, Bak AM, Høgild M, Pedersen SB, Biensø RS, Pilegaard H, Møller N, Jessen N, Jørgensen JO. Growth hormone-induced insulin resistance in human subjects involves reduced pyruvate dehydrogenase activity. Acta Physiol (Oxf). 2014 Feb;210(2):392-402. doi: 10.1111/apha.12183. Epub 2013 Nov 22.

Responsible Party:	Birgitte Nellemann, MD PhD student, University of Aarhus
ClinicalTrials.gov Identifier:	NCT01209429 History of Changes
Other Study ID Numbers:	M-20100150
First Posted:	September 27, 2010
Last Update Posted:	September 13, 2011
Last Verified:	September 2011

Keywords provided by Birgitte Nellemann, University of Aarhus:

Calorie restriction; GH/IGF-I axis; STATb5; SIRT1	Intracellular signaling peptides and proteins; Fasting; Growth hormone; IGF-1

Additional relevant MeSH terms:

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs