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

NCT ID: NCT01209429

Last Updated: 2011-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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42 hour fast/GH infusion

Group Type EXPERIMENTAL

GH hormone infusion

Intervention Type DRUG

Norditropin 30 ng/kg/min

42 hour fast

Intervention Type BEHAVIORAL

The participant will be fasting 42 hours prior to the start of the study day, drinking water is allowed

42 hour fast/Placebo infusion

Group Type EXPERIMENTAL

42 hour fast

Intervention Type BEHAVIORAL

The participant will be fasting 42 hours prior to the start of the study day, drinking water is allowed

12 hour fast/GH infusion

Group Type EXPERIMENTAL

GH hormone infusion

Intervention Type DRUG

Norditropin 30 ng/kg/min

12 hour fast

Intervention Type BEHAVIORAL

12 hour fast will be used as a control scenario to 42 hour fast

12 hour fast/Placebo infusion

Group Type PLACEBO_COMPARATOR

12 hour fast

Intervention Type BEHAVIORAL

12 hour fast will be used as a control scenario to 42 hour fast

Interventions

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GH hormone infusion

Norditropin 30 ng/kg/min

Intervention Type DRUG

42 hour fast

The participant will be fasting 42 hours prior to the start of the study day, drinking water is allowed

Intervention Type BEHAVIORAL

12 hour fast

12 hour fast will be used as a control scenario to 42 hour fast

Intervention Type BEHAVIORAL

Other Intervention Names

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Norditropin Genotropin No other name No other name

Eligibility Criteria

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Inclusion Criteria

* healthy lean men
* age \>18

Exclusion Criteria

* metabolic disturbances
* alcohol drug abuse
* malign disease: current or previous
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Birgitte Nellemann

MD PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jens Otto L Jørgensen, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Aarhus

Locations

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University Hospital of Aarhus, Norrebrogade

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 31668393 (View on PubMed)

Nellemann 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.

Reference Type DERIVED
PMID: 24148194 (View on PubMed)

Other Identifiers

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M-20100150

Identifier Type: -

Identifier Source: org_study_id

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