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Effect of Growth Hormone on Insulin Signaling in Muscle Tissue

This study has been completed.
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00477997
First received: May 23, 2007
Last updated: April 20, 2009
Last verified: April 2009
History of Changes
  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: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
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:

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
Placebo Comparator: 1
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 by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by University of Aarhus:
Growth Hormone
Insulin Signaling
GH signaling

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hormones
 Insulin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents

ClinicalTrials.gov processed this record on May 23, 2013