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Effect of Growth Hormone on Insulin Signaling in Muscle Tissue

Primary Purpose

Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Physiological Bolus of Growth Hormone
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insulin Resistance focused on measuring Growth Hormone, Insulin Signaling, GH signaling

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Department M (endocrinology and diabetes)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Other

Other

Arm Label

1

2

3

Arm Description

Saline bolus + OGTT

GH-bolus and OGTT

GH-bolus

Outcomes

Primary Outcome Measures

PI3-kinase activity i muscle tissue

Secondary Outcome Measures

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

Full Information

First Posted
May 23, 2007
Last Updated
April 20, 2009
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00477997
Brief Title
Effect of Growth Hormone on Insulin Signaling in Muscle Tissue
Official Title
The Effect of a Physiological Bolus of Growth Hormone (GH) on Insulin Signaling Pathways in Muscle Tissue From Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
Growth Hormone, Insulin Signaling, GH signaling

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Saline bolus + OGTT
Arm Title
2
Arm Type
Other
Arm Description
GH-bolus and OGTT
Arm Title
3
Arm Type
Other
Arm Description
GH-bolus
Intervention Type
Device
Intervention Name(s)
Physiological Bolus of Growth Hormone
Intervention Description
0,5 mg Norditropin
Primary Outcome Measure Information:
Title
PI3-kinase activity i muscle tissue
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Growth Hormone Signaling Proteins in Muscle Tissue and other Insulin Signaling Proteins in Muscle Tissue
Time Frame
2 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male Healthy Age between 18 and 30 years BMI ≤ 26 Exclusion Criteria: Known present disease including diabetes mellitus BMI > 26 Uses any medication Consumes > 21 units of alcohol per week
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Otto L Jørgensen, MD, DMSc
Organizational Affiliation
Department M (endocrinology and diabetes), Aarhus University Hospital, Norrebrogade 44, 8000 Aarhus C, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department M (endocrinology and diabetes)
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
21559284
Citation
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.
Results Reference
derived

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Effect of Growth Hormone on Insulin Signaling in Muscle Tissue

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