Growth Hormone Signaling in Vivo in Humans

NCT00512473 | Completed

• 1 other identifier: 20050113
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: GH induces insulin resistance in muscle and fat and in vitro data indicate that this may involve crosstalk between the signaling pathways of the two hormones. Aim: To investigate GH and insulin signaling in vivo in human muscle and fat tissue in response to GH, GH receptor blockade and insulin stimulation..

Conditions

Intracellular Signaling Peptides and Proteins

Keywords

GH, GH receptor blockade, GH signaling, insulin resistance

Outcome Measures

Primary Outcomes (1)

• GH-receptor signaling

  hours

Secondary Outcomes (1)

• Insulin sensitivity

  hours

Study Arms (3)

A

PLACEBO COMPARATOR

I.v. saline for 8 hours

Drug: Saline infusion

GH

EXPERIMENTAL

Growth hormone (0.5 mg s.c. at t = 0 hours)

Drug: Human Growth Hormone

Pegvisomant

EXPERIMENTAL

Pegvisomant injection 30 mg 36 hours prior to the study

Drug: Pegvisomant

Interventions

Saline infusion DRUG

0.9 % NaCl

A

Human Growth Hormone DRUG

0.5 mg genotropin administered as a bolus at t = 0

GH

Pegvisomant DRUG

30 mg Somavert administered at t = - 36 hours

Pegvisomant

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Healthy
• Not taking medication

You may not qualify if:

• Insulin resistance

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Medical Research Laboratories

Aarhus, 8000, Denmark

Location

Related Publications (3)

• Gormsen LC, Nielsen C, Gjedsted J, Gjedde S, Vestergaard ET, Christiansen JS, Jorgensen JO, Moller N. Effects of free fatty acids, growth hormone and growth hormone receptor blockade on serum ghrelin levels in humans. Clin Endocrinol (Oxf). 2007 May;66(5):641-5. doi: 10.1111/j.1365-2265.2007.02786.x.

  PMID: 17492951 RESULT

• Gormsen LC, Nielsen C, Jessen N, Jorgensen JO, Moller N. Time-course effects of physiological free fatty acid surges on insulin sensitivity in humans. Acta Physiol (Oxf). 2011 Mar;201(3):349-56. doi: 10.1111/j.1748-1716.2010.02181.x. Epub 2010 Oct 11.

  PMID: 20731625 DERIVED

• Nielsen C, Gormsen LC, Jessen N, Pedersen SB, Moller N, Lund S, Jorgensen JO. Growth hormone signaling in vivo in human muscle and adipose tissue: impact of insulin, substrate background, and growth hormone receptor blockade. J Clin Endocrinol Metab. 2008 Jul;93(7):2842-50. doi: 10.1210/jc.2007-2414. Epub 2008 May 6.

  PMID: 18460563 DERIVED

MeSH Terms

Conditions

Insulin Resistance

Interventions

Human Growth Hormone; pegvisomant

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Lars C Gormsen, MD

  Aarhus University Hospital, Department M

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 7, 2007
• Study Start: September 1, 2005
• Study Completion: April 1, 2006
• Last Updated: August 7, 2007

Record last verified: 2007-08

Locations

DK (1)