NCT00477997

Brief Summary

The purpose of this study is to examine the effects of a physiological bolus of growth hormone on insulin signaling pathways in muscle tissue in healthy lean men.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2007

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

May 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

April 21, 2009

Status Verified

April 1, 2009

Enrollment Period

11 months

First QC Date

May 23, 2007

Last Update Submit

April 20, 2009

Conditions

Insulin Resistance

Keywords

Growth HormoneInsulin SignalingGH signaling

Outcome Measures

Primary Outcomes (1)

  • PI3-kinase activity i muscle tissue

    2 hours

Secondary Outcomes (1)

  • Growth Hormone Signaling Proteins in Muscle Tissue and other Insulin Signaling Proteins in Muscle Tissue

    2 hours

Study Arms (3)

1

PLACEBO COMPARATOR

Saline bolus + OGTT

Device: Physiological Bolus of Growth Hormone

2

OTHER

GH-bolus and OGTT

Device: Physiological Bolus of Growth Hormone

3

OTHER

GH-bolus

Device: Physiological Bolus of Growth Hormone

Interventions

Physiological Bolus of Growth HormoneDEVICE

0,5 mg Norditropin

123

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Healthy
  • Age between 18 and 30 years
  • BMI ≤ 26

You may not qualify if:

  • Known present disease including diabetes mellitus
  • BMI \> 26
  • Uses any medication
  • Consumes \> 21 units of alcohol per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department M (endocrinology and diabetes)

Aarhus, Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Krusenstjerna-Hafstrom T, Madsen M, Vendelbo MH, Pedersen SB, Christiansen JS, Moller N, Jessen N, Jorgensen JO. Insulin and GH signaling in human skeletal muscle in vivo following exogenous GH exposure: impact of an oral glucose load. PLoS One. 2011 May 3;6(5):e19392. doi: 10.1371/journal.pone.0019392.

    PMID: 21559284DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jens Otto L Jørgensen, MD, DMSc

    Department M (endocrinology and diabetes), Aarhus University Hospital, Norrebrogade 44, 8000 Aarhus C, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 23, 2007

First Posted

May 24, 2007

Study Start

May 1, 2007

Primary Completion

April 1, 2008

Study Completion

August 1, 2008

Last Updated

April 21, 2009

Record last verified: 2009-04

Locations

DK(1)