Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
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
  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 Blind (Subject)
Primary Purpose: Basic Science
Official Title: Importance of the GH/IGF-1 Axis for Human Substrate and Energy Metabolism During Calorie Restriction

Resource links provided by NLM:

MedlinePlus related topics: Hormones
Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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
Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Birgitte Nellemann, MD PhD student, University of Aarhus
ClinicalTrials.gov Identifier: NCT01209429     History of Changes
Other Study ID Numbers: M-20100150
Study First Received: September 24, 2010
Last Updated: September 12, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Calorie restriction
GH/IGF-I axis
STATb5
SIRT1
 Intracellular signaling peptides and proteins
Fasting
Growth hormone
IGF-1

ClinicalTrials.gov processed this record on February 27, 2015