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

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.
 
ClinicalTrials.gov Identifier: NCT01209429
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : September 13, 2011
Sponsor:
Information provided by (Responsible Party):
Birgitte Nellemann, University of Aarhus

Study Description
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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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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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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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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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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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
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Denmark
University Hospital of Aarhus, Norrebrogade
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Jens Otto L Jørgensen, Professor University Hospital of Aarhus
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Birgitte Nellemann, MD PhD student, University of Aarhus
ClinicalTrials.gov Identifier: NCT01209429    
Other Study ID Numbers: M-20100150
First Posted: September 27, 2010    Key Record Dates
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:
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Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs