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
About this trial
This is an interventional basic science trial for Insulin Resistance focused on measuring Growth Hormone, Insulin Signaling, GH signaling
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
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
NCT ID
NCT00477997
First Posted
May 23, 2007
Last Updated
April 20, 2009
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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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