Importance of the GH/IGF-1 Axis for Human Substrate and Energy Metabolism During Calorie Restriction
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Sep 2010
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 24, 2010
CompletedFirst Posted
Study publicly available on registry
September 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedSeptember 13, 2011
September 1, 2011
1 year
September 24, 2010
September 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Description of intracellular pathways to clarify the interplay between calorie restriction, SIRT1, STATb5, and the GH/IGF-I axis
All study days consists of 3 hour basic periods and 3 hours hyperinsulinemic, euglycemic clamp.
6 hour study days
Study Arms (4)
42 hour fast/GH infusion
EXPERIMENTAL42 hour fast/Placebo infusion
EXPERIMENTAL12 hour fast/GH infusion
EXPERIMENTAL12 hour fast/Placebo infusion
PLACEBO COMPARATORInterventions
Norditropin 30 ng/kg/min
The participant will be fasting 42 hours prior to the start of the study day, drinking water is allowed
12 hour fast will be used as a control scenario to 42 hour fast
Eligibility Criteria
You may qualify if:
- healthy lean men
- age \>18
You may not qualify if:
- metabolic disturbances
- alcohol drug abuse
- malign disease: current or previous
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Aarhus, Norrebrogade
Aarhus, 8000, Denmark
Related Publications (2)
Hjelholt AJ, Lee KY, Arlien-Soborg MC, Pedersen SB, Kopchick JJ, Puri V, Jessen N, Jorgensen JOL. Temporal patterns of lipolytic regulators in adipose tissue after acute growth hormone exposure in human subjects: A randomized controlled crossover trial. Mol Metab. 2019 Nov;29:65-75. doi: 10.1016/j.molmet.2019.08.013. Epub 2019 Aug 20.
PMID: 31668393DERIVEDNellemann B, Vendelbo MH, Nielsen TS, Bak AM, Hogild M, Pedersen SB, Bienso RS, Pilegaard H, Moller N, Jessen N, Jorgensen 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.
PMID: 24148194DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jens Otto L Jørgensen, Professor
University Hospital of Aarhus
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD student
Study Record Dates
First Submitted
September 24, 2010
First Posted
September 27, 2010
Study Start
September 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
September 13, 2011
Record last verified: 2011-09