Effect of Growth Hormone on Insulin Signaling in Muscle Tissue

This study has been completed.

First Received: May 23, 2007 Last Updated: April 20, 2009 History of Changes

Sponsor:	University of Aarhus
Collaborator:	Aarhus University Hospital
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00477997

Purpose

The purpose of this study is to examine the effects of a physiological bolus of growth hormone on insulin signaling pathways in muscle tissue in healthy lean men.

Condition	Intervention
Insulin Resistance	Device: Physiological Bolus of Growth Hormone

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Subject), Placebo Control, Factorial Assignment
Official Title:	The Effect of a Physiological Bolus of Growth Hormone (GH) on Insulin Signaling Pathways in Muscle Tissue From Healthy Adults

Resource links provided by NLM:

Drug Information available for: Insulin Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

PI3-kinase activity i muscle tissue [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Growth Hormone Signaling Proteins in Muscle Tissue and other Insulin Signaling Proteins in Muscle Tissue [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	8
Study Start Date:	May 2007
Study Completion Date:	August 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Saline bolus + OGTT	Device: Physiological Bolus of Growth Hormone 0,5 mg Norditropin
2 GH-bolus and OGTT	Device: Physiological Bolus of Growth Hormone 0,5 mg Norditropin
3 GH-bolus	Device: Physiological Bolus of Growth Hormone 0,5 mg Norditropin

Eligibility

Ages Eligible for Study:	18 Years to 30 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male
Healthy
Age between 18 and 30 years
BMI ≤ 26

Exclusion Criteria:

Known present disease including diabetes mellitus
BMI > 26
Uses any medication
Consumes > 21 units of alcohol per week

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477997

Locations

Denmark
Department M (endocrinology and diabetes)
Aarhus, Denmark, 8000

Sponsors and Collaborators

University of Aarhus

Aarhus University Hospital

Investigators

Principal Investigator:

Jens Otto L Jørgensen, MD, DMSc

Department M (endocrinology and diabetes), Aarhus University Hospital, Norrebrogade 44, 8000 Aarhus C, Denmark

More Information

No publications provided

Responsible Party:	Aarhus University Hospital ( Jens Otto Lunde Jørgensen )
Study ID Numbers:	MM-GH-20070052
Study First Received:	May 23, 2007
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00477997 History of Changes
Health Authority:	Denmark: Ethics Committee

Keywords provided by University of Aarhus:

Growth Hormone
Insulin Signaling
GH signaling

Additional relevant MeSH terms:

Hyperinsulinism
Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Insulin Resistance
Glucose Metabolism Disorders
Hormones
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on February 08, 2010