Effect of Growth Hormone on Insulin Signaling in Muscle Tissue

• Sponsor: University of Aarhus (Other)
• Overall Status: Completed
• CT.gov ID: NCT00477997
• Collaborator: Aarhus University Hospital (Other)
• Enrollment: 8
• Location: 1
• Arms: 3
• Duration (Months): 15
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Insulin Resistance	Device: Physiological Bolus of Growth Hormone	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Participant)
• 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
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1 Saline bolus + OGTT	Device: Physiological Bolus of Growth Hormone; 0,5 mg Norditropin
Other: 2 GH-bolus and OGTT	Device: Physiological Bolus of Growth Hormone; 0,5 mg Norditropin
Other: 3 GH-bolus	Device: Physiological Bolus of Growth Hormone; 0,5 mg Norditropin

Outcome Measures

Primary Outcome Measures

1. PI3-kinase activity i muscle tissue [2 hours]

Secondary Outcome Measures

1. Growth Hormone Signaling Proteins in Muscle Tissue and other Insulin Signaling Proteins in Muscle Tissue [2 hours]

Eligibility Criteria

Criteria

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

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00477997
• Other Study ID Numbers: MM-GH-20070052
• First Posted: May 24, 2007
• Last Update Posted: Apr 21, 2009
• Last Verified: Apr 1, 2009

• Keywords provided by , ,: Growth Hormone; Insulin Signaling; GH signaling
• Additional relevant MeSH terms: Insulin Resistance; Hormones

Study Results

No Results Posted as of Apr 21, 2009