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NCT Number: NCT02782221

Lipolytic Effects of GH in Human Subjects in Vivo

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.

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Key information

Conditions

Metabolic Diseases Growth Hormone Treatment Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Aarhus

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy males
  • no medication
  • BMI 28-35

Exclusion criteria

  • known diseases
  • regular medication

Treatment and study plan

growth hormone

Drug

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

Other names: Genotropin

Pegisomant

Drug

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

Other names: Somavert

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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Lipolytic Effects of GH in Human Subjects in Vivo: Molecular Mechanisms and Temporal Patterns

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
May 25, 2016
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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