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Lipolytic Effects of GH in Human Subjects in Vivo

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ClinicalTrials.gov Identifier: NCT02782221
Recruitment Status : Unknown
Verified May 2016 by University of Aarhus.
Recruitment status was:  Recruiting
First Posted : May 25, 2016
Last Update Posted : May 25, 2016
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.


Condition or disease Intervention/treatment Phase
Metabolic Diseases Growth Hormone Treatment Drug: Growth Hormone Drug: Pegisomant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Lipolytic Effects of GH in Human Subjects in Vivo: Molecular Mechanisms and Temporal Patterns
Study Start Date : May 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Active Comparator: Growth hormone
Subjects are receiving growth hormone
Drug: Growth Hormone
Subjects are receiving one injection of growth hormone (Genotropin) 0,5 mg
Other Name: Genotropin

Placebo Comparator: Placebo
Subjects are receiving pegvisomant to block the action of growth hormone
Drug: Pegisomant
One the placebo day the subjects are receiving injection with pegvisomant (Somavert 30 mg) to block the action of endogenous growth hormone
Other Name: Somavert




Primary Outcome Measures :
  1. Lipolytic activity measured as area under the curve (AUC) for FFA (blood sample). [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Substrate metabolism as measured by indirect calorimetry [ Time Frame: 3 months ]
  2. GH signaling proteins in adipose tissue measured by western blotting [ Time Frame: 1,5 years ]
  3. Intracellular lipolytic activity measured by an ATGL assay [ Time Frame: 1 year ]
  4. GH signaling gene targets in adipose tissue measured by qPCR [ Time Frame: 1,5 years ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy males
  • no medication
  • BMI 28-35

Exclusion Criteria:

  • known diseases
  • regular medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782221


Contacts
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Contact: Astrid J Hjelholt, MD +4524800664 ajh@clin.au.dk
Contact: Jens Otto L Jørgensen, Professor +4520727383 joj@clin.au.dk

Locations
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Denmark
University Hospital of Aarhus Recruiting
Aarhus, Denmark, 8000
Contact: Astrid J Hjelholt, MD    +4524800664    ajh@clin.au.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Jens Otto L Jørgensen, Professor University Hospital of Aarhus

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02782221     History of Changes
Other Study ID Numbers: GH02
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Aarhus:
lipolysis
ATGL
Additional relevant MeSH terms:
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Metabolic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs