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Growth Hormone During Fasting.Signaltransduktion in Muscle and Adipose Tissue and Changes in Intrahepatic Lipid Content

NCT ID: NCT00476879

Last Updated: 2008-08-12

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

2006-08-31

Study Completion Date

2008-06-30

Brief Summary

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The purpose of this study is to examine the effects of growth hormone during fasting in healthy lean men.

Detailed Description

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During fasting the human body is known to metabolize relatively large amounts of fat, in the expense of proteins and glucose. Partly this shift in metabolism is caused by increasing GH secretion, but exactly how growth hormone exerts these effects remains to be further investigated.

10 healthy lean young men are studied at 4 different occasions in a randomized single-blinded cross-over study. 1: after 12 hours of fasting + GH bolus, 2: after 36 hours of fasting + GH bolus, 3: after 36 hours + saline, 4: after 36 hours of fasting + Somavert.

Aim:

* to study the signal transduction in muscle and fat tissue
* to study the metabolism during fasting
* to study the intrahepatic fat content using magnetic resonance techniques

Conditions

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Metabolism Fatty Liver

Keywords

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Growth hormone Fasting Signaltransduction fatty liver insulin sensitivity forearm model protein metabolism respiratory quotient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

12 hours of fasting and a GH bolus

Group Type EXPERIMENTAL

Somatropin and pegvisomant

Intervention Type DRUG

Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml

2

36 hours of fasting and a GH bolus

Group Type EXPERIMENTAL

Somatropin and pegvisomant

Intervention Type DRUG

Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml

3

36 hours of fasting and Pegvisomant

Group Type EXPERIMENTAL

Somatropin and pegvisomant

Intervention Type DRUG

Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml

4

36 hours of fasting and NaCl injection

Group Type EXPERIMENTAL

Somatropin and pegvisomant

Intervention Type DRUG

Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml

Interventions

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Somatropin and pegvisomant

Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* male
* healthy
* age 20 - 40 years of age
* BMI 20 -25

Exclusion Criteria

* uses any medication
* drinks more than 21 units of alcohol per
* is claustrophobic
* carries any magnetic devices
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus

Principal Investigators

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Louise Moller, MD

Role: PRINCIPAL_INVESTIGATOR

Medical department M, Aarhus Sygehus, Norrebrogade 44, 8000 Aarhus, Denmark

Locations

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Medical department M, Arhus Sygehus, Region midtjylland

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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Moller L, Norrelund H, Jessen N, Flyvbjerg A, Pedersen SB, Gaylinn BD, Liu J, Thorner MO, Moller N, Lunde Jorgensen JO. Impact of growth hormone receptor blockade on substrate metabolism during fasting in healthy subjects. J Clin Endocrinol Metab. 2009 Nov;94(11):4524-32. doi: 10.1210/jc.2009-0381. Epub 2009 Oct 9.

Reference Type DERIVED
PMID: 19820031 (View on PubMed)

Other Identifiers

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090600-deleted

Identifier Type: -

Identifier Source: org_study_id