Lipolytic Effects of GH in Human Subjects in Vivo

Metabolic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782221
• Other study ID #: GH02
• Status: Completed
• Phase: N/A
• Start date: May 30, 2016
• Est. completion date: January 15, 2017

Study information

• Verified date: October 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 15, 2017
• Est. primary completion date: September 22, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• healthy males

• no medication

• BMI 28-35

Exclusion Criteria:

• known diseases

• regular medication

Related Conditions & MeSH terms

• Growth Hormone Treatment
• Metabolic Diseases

Intervention

Drug:
• Growth Hormone
Subjects are receiving one injection of growth hormone (Genotropin) 0,5 mg
• Pegisomant
One the placebo day the subjects are receiving injection with pegvisomant (Somavert 30 mg) to block the action of endogenous growth hormone

Locations

Country	Name	City	State
Denmark	University Hospital of Aarhus	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Møller N, Jørgensen 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. Review. — View Citation

Nielsen TS, Jessen N, Jørgensen JO, Møller 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipolytic activity measured as area under the curve (AUC) for FFA (blood sample).		1 year
Secondary	Substrate metabolism as measured by indirect calorimetry		3 months
Secondary	GH signaling proteins in adipose tissue measured by western blotting		1,5 years
Secondary	Intracellular lipolytic activity measured by an ATGL assay		1 year
Secondary	GH signaling gene targets in adipose tissue measured by qPCR		1,5 years