Growth Hormone During Fasting.Signaltransduktion in Muscle and Adipose Tissue and Changes in Intrahepatic Lipid Content

August 11, 2008 updated by: University of Aarhus

Growth Hormone During Fasting. Signaltransduktion in Muscle and Adipose Tissue, Consequence of Growth Hormone Receptor Antagonist, Quantification of Intrahepatic Lipid Content Based on MR Scanning

The purpose of this study is to examine the effects of growth hormone during fasting in healthy lean men.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During fasting the human body is known to metabolize relatively large amounts of fat, in the expense of proteins and glucose. Partly this shift in metabolism is caused by increasing GH secretion, but exactly how growth hormone exerts these effects remains to be further investigated.

10 healthy lean young men are studied at 4 different occasions in a randomized single-blinded cross-over study. 1: after 12 hours of fasting + GH bolus, 2: after 36 hours of fasting + GH bolus, 3: after 36 hours + saline, 4: after 36 hours of fasting + Somavert.

Aim:

  • to study the signal transduction in muscle and fat tissue
  • to study the metabolism during fasting
  • to study the intrahepatic fat content using magnetic resonance techniques

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Medical department M, Arhus Sygehus, Region midtjylland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • male
  • healthy
  • age 20 - 40 years of age
  • BMI 20 -25

Exclusion Criteria:

  • uses any medication
  • drinks more than 21 units of alcohol per
  • is claustrophobic
  • carries any magnetic devices

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
12 hours of fasting and a GH bolus
Drug: Somatropin and pegvisomant
Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml
Experimental: 2
36 hours of fasting and a GH bolus
Drug: Somatropin and pegvisomant
Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml
Experimental: 3
36 hours of fasting and Pegvisomant
Drug: Somatropin and pegvisomant
Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml
Experimental: 4
36 hours of fasting and NaCl injection
Drug: Somatropin and pegvisomant
Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in intrahepatic lipid content
Time Frame: 12 and 36 hours of fasting. respectively
12 and 36 hours of fasting. respectively
changes in intracellular signaling during fasting
Time Frame: 36 hours
36 hours
changes in respiratory quotient
Time Frame: 36 hours of fasting
36 hours of fasting
metabolism
Time Frame: 36 hours of fasting
36 hours of fasting
insulin sensitivity
Time Frame: 36 hours of fasting
36 hours of fasting
forearm metabolism
Time Frame: 36 hours of fasting
36 hours of fasting

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in FFA
Time Frame: 36 hours of fasting
36 hours of fasting
Changes in grelin
Time Frame: 36 hours of fasting
36 hours of fasting
changes in leptin, adiponektin, cortisol, catecholamine, glucagon, carbamide, palmitate
Time Frame: 36 hours of fasting
36 hours of fasting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Pfizer
Aarhus University Hospital

Investigators

  • Principal Investigator: Louise Moller, MD, Medical department M, Aarhus Sygehus, Norrebrogade 44, 8000 Aarhus, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

May 21, 2007

First Submitted That Met QC Criteria

May 21, 2007

First Posted (Estimate)

May 22, 2007

Study Record Updates

Last Update Posted (Estimate)

August 12, 2008

Last Update Submitted That Met QC Criteria

August 11, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 090600-deleted

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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