Lipolytic Effects of GH in Human Subjects in Vivo

March 25, 2020 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • University Hospital of Aarhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy males
  • no medication
  • BMI 28-35

Exclusion Criteria:

  • known diseases
  • regular medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Somavert

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Jens Otto L Jørgensen, Professor, University Hospital of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2016

Primary Completion (Actual)

September 22, 2016

Study Completion (Actual)

January 15, 2017

Study Registration Dates

First Submitted

May 18, 2016

First Submitted That Met QC Criteria

May 20, 2016

First Posted (Estimate)

May 25, 2016

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GH02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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