Lipolytic Effects of GH in Human Subjects in Vivo

NCT ID: NCT02782221

Last Updated: 2020-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-30

Study Completion Date

2017-01-15

Brief Summary

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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.

Detailed Description

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Conditions

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Metabolic Diseases Growth Hormone Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Growth hormone

Subjects are receiving growth hormone

Group Type ACTIVE_COMPARATOR

Growth Hormone

Intervention Type DRUG

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

Placebo

Subjects are receiving pegvisomant to block the action of growth hormone

Group Type PLACEBO_COMPARATOR

Pegisomant

Intervention Type DRUG

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

Interventions

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Growth Hormone

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

Intervention Type DRUG

Pegisomant

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

Intervention Type DRUG

Other Intervention Names

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Genotropin Somavert

Eligibility Criteria

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Inclusion Criteria

* healthy males
* no medication
* BMI 28-35

Exclusion Criteria

* known diseases
* regular medication
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jens Otto L Jørgensen, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Aarhus

Locations

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University Hospital of Aarhus

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 24577718 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19240267 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31668393 (View on PubMed)

Other Identifiers

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GH02

Identifier Type: -

Identifier Source: org_study_id

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