Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Birgitte Nellemann, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01209429
First received: September 24, 2010
Last updated: September 12, 2011
Last verified: September 2011
History of Changes

September 24, 2010
September 12, 2011
September 2010
September 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
All study days consists of 3 hour basic periods and 3 hours hyperinsulinemic, euglycemic clamp.
Same as current
Complete list of historical versions of study NCT01209429 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Importance of the GH/IGF-1 Axis for Human Substrate and Energy Metabolism During Calorie Restriction
Importance of the GH/IGF-1 Axis for Human Substrate and Energy Metabolism During Calorie Restriction

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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Healthy
  • 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
  • Behavioral: 12 hour fast
    12 hour fast will be used as a control scenario to 42 hour fast
    Other Name: No other name
  • Experimental: 42 hour fast/GH infusion
    Interventions:
    • Drug: GH hormone infusion
    • Behavioral: 42 hour fast
  • Experimental: 42 hour fast/Placebo infusion
    Intervention: Behavioral: 42 hour fast
  • Experimental: 12 hour fast/GH infusion
    Interventions:
    • Drug: GH hormone infusion
    • Behavioral: 12 hour fast
  • Placebo Comparator: 12 hour fast/Placebo infusion
    Intervention: Behavioral: 12 hour fast
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy lean men
  • age >18

Exclusion Criteria:

  • metabolic disturbances
  • alcohol drug abuse
  • malign disease: current or previous
Male
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01209429
M-20100150
No
Birgitte Nellemann, University of Aarhus
University of Aarhus
Not Provided
Principal Investigator: Jens Otto L Jørgensen, Professor University Hospital of Aarhus
University of Aarhus
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP