NCT02782221

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

May 30, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2017

Completed
Last Updated

March 26, 2020

Status Verified

October 1, 2017

Enrollment Period

4 months

First QC Date

May 18, 2016

Last Update Submit

March 25, 2020

Conditions

Metabolic DiseasesGrowth Hormone Treatment

Keywords

lipolysisATGL

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (4)

  • Substrate metabolism as measured by indirect calorimetry

    3 months

  • GH signaling proteins in adipose tissue measured by western blotting

    1,5 years

  • Intracellular lipolytic activity measured by an ATGL assay

    1 year

  • GH signaling gene targets in adipose tissue measured by qPCR

    1,5 years

Study Arms (2)

Growth hormone

ACTIVE COMPARATOR

Subjects are receiving growth hormone

Drug: Growth Hormone

Placebo

PLACEBO COMPARATOR

Subjects are receiving pegvisomant to block the action of growth hormone

Drug: Pegisomant

Interventions

Growth HormoneDRUG

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

Also known as: Genotropin
Growth hormone
PegisomantDRUG

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
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy males
  • no medication
  • BMI 28-35

You may not qualify if:

  • known diseases
  • regular medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Aarhus

Aarhus, 8000, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 24577718BACKGROUND

  • 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.

    PMID: 19240267BACKGROUND

  • 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.

    PMID: 31668393DERIVED

MeSH Terms

Conditions

Metabolic Diseases

Interventions

Growth HormoneHuman Growth Hormonepegvisomant

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Jens Otto L Jørgensen, Professor

    University Hospital of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 25, 2016

Study Start

May 30, 2016

Primary Completion

September 22, 2016

Study Completion

January 15, 2017

Last Updated

March 26, 2020

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)