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Importance of the GH/IGF-1 Axis for Human Substrate and Energy Metabolism During Calorie Restriction
This study has been completed.
Sponsor:
University of Aarhus
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
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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 (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:
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:
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 (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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01209429
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
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 |
ClinicalTrials.gov processed this record on June 23, 2017