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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01209429

First Posted: September 27, 2010

Last Update Posted: September 13, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Birgitte Nellemann, University of Aarhus

Purpose

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	Intervention
Healthy	Drug: GH hormone infusion Behavioral: 42 hour fast Behavioral: 12 hour fast


Study Type:	Interventional
Study Design:	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

Further study details as provided by Birgitte Nellemann, University of Aarhus:

Primary Outcome Measures:

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.


Estimated Enrollment:	10
Study Start Date:	September 2010
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01209429

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

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 Submitted:	September 24, 2010
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

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