NCT00476879

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

August 12, 2008

Status Verified

August 1, 2008

Enrollment Period

1.3 years

First QC Date

May 21, 2007

Last Update Submit

August 11, 2008

Conditions

MetabolismFatty Liver

Keywords

Growth hormoneFastingSignaltransductionfatty liverinsulin sensitivityforearm modelprotein metabolismrespiratory quotient

Outcome Measures

Primary Outcomes (6)

  • changes in intrahepatic lipid content

    12 and 36 hours of fasting. respectively

  • changes in intracellular signaling during fasting

    36 hours

  • changes in respiratory quotient

    36 hours of fasting

  • metabolism

    36 hours of fasting

  • insulin sensitivity

    36 hours of fasting

  • forearm metabolism

    36 hours of fasting

Secondary Outcomes (3)

  • changes in FFA

    36 hours of fasting

  • Changes in grelin

    36 hours of fasting

  • changes in leptin, adiponektin, cortisol, catecholamine, glucagon, carbamide, palmitate

    36 hours of fasting

Study Arms (4)

1

EXPERIMENTAL

12 hours of fasting and a GH bolus

Drug: Somatropin and pegvisomant

2

EXPERIMENTAL

36 hours of fasting and a GH bolus

Drug: Somatropin and pegvisomant

3

EXPERIMENTAL

36 hours of fasting and Pegvisomant

Drug: Somatropin and pegvisomant

4

EXPERIMENTAL

36 hours of fasting and NaCl injection

Drug: Somatropin and pegvisomant

Interventions

Somatropin and pegvisomantDRUG

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

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Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • uses any medication
  • drinks more than 21 units of alcohol per
  • is claustrophobic
  • carries any magnetic devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical department M, Arhus Sygehus, Region midtjylland

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 19820031DERIVED

MeSH Terms

Conditions

Fatty LiverFastingInsulin Resistance

Interventions

Human Growth Hormonepegvisomant

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFeeding BehaviorBehaviorHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Louise Moller, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 21, 2007

First Posted

May 22, 2007

Study Start

August 1, 2006

Primary Completion

November 1, 2007

Study Completion

June 1, 2008

Last Updated

August 12, 2008

Record last verified: 2008-08

Locations

DK(1)