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CompletedNCT02782221Updated Mar 26, 2020

Lipolytic Effects of GH in Human Subjects in Vivo

An interventional study of Growth Hormone and Pegisomant in Metabolic Diseases and Growth Hormone Treatment, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-26.

Sponsored by University of Aarhus · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Metabolic Diseases
  • Growth Hormone Treatment

Browse trials for

Keywords

  • lipolysis
  • ATGL
03

In context

Metabolic Diseases

997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.

This study's enrollment of 9 is below the median of 48 across 670 interventional studies indexed under Metabolic Diseases.

Browse Metabolic Diseases studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy males
  • no medication
  • BMI 28-35

Exclusion criteria

Exclusion Criteria:

  • known diseases
  • regular medication
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
9 participants (actual)

Study arms

  • Active comparator
    Growth hormone

    Subjects are receiving growth hormone

    Drug: Growth Hormone

  • Placebo comparator
    Placebo

    Subjects are receiving pegvisomant to block the action of growth hormone

    Drug: Pegisomant

Interventions

  • DrugGrowth Hormone

    Subjects are receiving one injection of growth hormone (Genotropin) 0,5 mg

    Also known as: Genotropin

  • DrugPegisomant

    One the placebo day the subjects are receiving injection with pegvisomant (Somavert 30 mg) to block the action of endogenous growth hormone

    Also known as: Somavert

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What researchers measure

Primary outcomes

  1. Lipolytic activity measured as area under the curve (AUC) for FFA (blood sample).

    Time frame: 1 year

Secondary outcomes

  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

07

Study locations

1 site
  • University Hospital of Aarhus
    Aarhus, 8000, Denmark
08

References and documents

Publications

  • 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. PubMed 24577718 ↗
  • 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. PubMed 19240267 ↗
  • 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. PubMed 31668393 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02782221
Lead sponsor
University of Aarhus
Responsible party
Sponsor
First posted
May 25, 2016
Start date
May 30, 2016
Primary completion
Sep 22, 2016
Completion
Jan 15, 2017
Last update
Mar 26, 2020

Study contacts

Jens Otto L Jørgensen, Professor
principal investigator · University Hospital of Aarhus

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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