Back to resultsLipolytic Effects of GH in Human Subjects in Vivo
Primary Purpose
Metabolic Diseases, Growth Hormone Treatment
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Growth Hormone
Pegisomant
Sponsored by
About this trial
This is an interventional basic science trial for Metabolic Diseases focused on measuring lipolysis, ATGL
Eligibility Criteria
Inclusion Criteria:
- healthy males
- no medication
- BMI 28-35
Exclusion Criteria:
- known diseases
- regular medication
Sites / Locations
- University Hospital of Aarhus
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Growth hormone
Placebo
Arm Description
Subjects are receiving growth hormone
Subjects are receiving pegvisomant to block the action of growth hormone
Outcomes
Primary Outcome Measures
Lipolytic activity measured as area under the curve (AUC) for FFA (blood sample).
Secondary Outcome Measures
Substrate metabolism as measured by indirect calorimetry
GH signaling proteins in adipose tissue measured by western blotting
Intracellular lipolytic activity measured by an ATGL assay
GH signaling gene targets in adipose tissue measured by qPCR
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02782221
Brief Title
Lipolytic Effects of GH in Human Subjects in Vivo
Official Title
Lipolytic Effects of GH in Human Subjects in Vivo: Molecular Mechanisms and Temporal Patterns
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 30, 2016 (Actual)
Primary Completion Date
September 22, 2016 (Actual)
Study Completion Date
January 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Growth hormone (GH) induces fat metabolism. The mechanisms underlying the fat metabolizing effects of GH remain elusive. However, it is known that insulin suppresses fat metabolism, and GH inhibits the expression of certain insulin-dependent signaling proteins. We therefore hypothesize that the fat metabolizing effects of GH depend on abrogation of insulin-dependent signaling pathways.
In order to investigate the fat metabolizing effects of GH, we'll analyze consecutive adipose tissue biopsies taken after GH exposure and GH blocking, respectively.
Knowledge of the effects of growth hormone and fat metabolism can in shot-sight as well as in long-sight have great importance for the understanding of growth disorders from overweight and type 2 diabetes to malnutrition and eating disorders.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Diseases, Growth Hormone Treatment
Keywords
lipolysis, ATGL
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Growth hormone
Arm Type
Active Comparator
Arm Description
Subjects are receiving growth hormone
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects are receiving pegvisomant to block the action of growth hormone
Intervention Type
Drug
Intervention Name(s)
Growth Hormone
Other Intervention Name(s)
Genotropin
Intervention Description
Subjects are receiving one injection of growth hormone (Genotropin) 0,5 mg
Intervention Type
Drug
Intervention Name(s)
Pegisomant
Other Intervention Name(s)
Somavert
Intervention Description
One the placebo day the subjects are receiving injection with pegvisomant (Somavert 30 mg) to block the action of endogenous growth hormone
Primary Outcome Measure Information:
Title
Lipolytic activity measured as area under the curve (AUC) for FFA (blood sample).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Substrate metabolism as measured by indirect calorimetry
Time Frame
3 months
Title
GH signaling proteins in adipose tissue measured by western blotting
Time Frame
1,5 years
Title
Intracellular lipolytic activity measured by an ATGL assay
Time Frame
1 year
Title
GH signaling gene targets in adipose tissue measured by qPCR
Time Frame
1,5 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy males
no medication
BMI 28-35
Exclusion Criteria:
known diseases
regular medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Otto L Jørgensen, Professor
Organizational Affiliation
University Hospital of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Aarhus
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24577718
Citation
Nielsen TS, Jessen N, Jorgensen JO, Moller N, Lund S. Dissecting adipose tissue lipolysis: molecular regulation and implications for metabolic disease. J Mol Endocrinol. 2014 Jun;52(3):R199-222. doi: 10.1530/JME-13-0277. Epub 2014 Feb 27.
Results Reference
background
PubMed Identifier
19240267
Citation
Moller N, Jorgensen JO. Effects of growth hormone on glucose, lipid, and protein metabolism in human subjects. Endocr Rev. 2009 Apr;30(2):152-77. doi: 10.1210/er.2008-0027. Epub 2009 Feb 24.
Results Reference
background
PubMed Identifier
31668393
Citation
Hjelholt AJ, Lee KY, Arlien-Soborg MC, Pedersen SB, Kopchick JJ, Puri V, Jessen N, Jorgensen JOL. Temporal patterns of lipolytic regulators in adipose tissue after acute growth hormone exposure in human subjects: A randomized controlled crossover trial. Mol Metab. 2019 Nov;29:65-75. doi: 10.1016/j.molmet.2019.08.013. Epub 2019 Aug 20.
Results Reference
derived
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Lipolytic Effects of GH in Human Subjects in Vivo
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