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Completed

NCT Number: NCT00476879

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

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

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Key information

Conditions

Metabolism Behavior Digestive System Diseases Fasting Fatty Liver Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Medical department M, Arhus Sygehus, Region midtjylland

Aarhus, 8000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatropin and pegvisomant

Drug

Somatropin are given intravenous, 0.5mg pegvisomant are given subcutaneous, 15 mg NaCl are given subcutaneous, 2 ml

Primary outcomes

  1. changes in intrahepatic lipid content

    Time frame: 12 and 36 hours of fasting. respectively

  2. changes in intracellular signaling during fasting

    Time frame: 36 hours

  3. changes in respiratory quotient

    Time frame: 36 hours of fasting

  4. metabolism

    Time frame: 36 hours of fasting

  5. insulin sensitivity

    Time frame: 36 hours of fasting

  6. forearm metabolism

    Time frame: 36 hours of fasting

Secondary outcomes

  1. changes in FFA

    Time frame: 36 hours of fasting

  2. Changes in grelin

    Time frame: 36 hours of fasting

  3. changes in leptin, adiponektin, cortisol, catecholamine, glucagon, carbamide, palmitate

    Time frame: 36 hours of fasting

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
May 22, 2007
Registry last updated
Aug 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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