Clinical trial NCT00476879: Growth Hormone During Fasting.Signaltransduktion in Muscle and Adipose Tissue and Changes in Intrahepatic Lipid Content
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolism
Fatty Liver
Keywords: Growth hormone
Fasting
Signaltransduction
fatty liver
insulin sensitivity
forearm model
protein metabolism
respiratory quotient
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Pfizer
First posted: 2007-05-22
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

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

Eligibility criteria: 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

Primary outcomes:
measure: changes in intrahepatic lipid content
timeFrame: 12 and 36 hours of fasting. respectively
measure: changes in intracellular signaling during fasting
timeFrame: 36 hours
measure: changes in respiratory quotient
timeFrame: 36 hours of fasting
measure: metabolism
timeFrame: 36 hours of fasting
measure: insulin sensitivity
timeFrame: 36 hours of fasting
measure: forearm metabolism
timeFrame: 36 hours of fasting
Secondary outcomes:
measure: changes in FFA
timeFrame: 36 hours of fasting
measure: Changes in grelin
timeFrame: 36 hours of fasting
measure: changes in leptin, adiponektin, cortisol, catecholamine, glucagon, carbamide, palmitate
timeFrame: 36 hours of fasting
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Medical department M, Arhus Sygehus, Region midtjylland
Study officials:
affiliation: Medical department M, Aarhus Sygehus, Norrebrogade 44, 8000 Aarhus, Denmark
name: Louise Moller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moller L, Norrelund H, Jessen N, Flyvbjerg A, Pedersen SB, Gaylinn BD, Liu J, Thorner MO, Moller N, Lunde Jorgensen JO. Impact of growth hormone receptor blockade on substrate metabolism during fasting in healthy subjects. J Clin Endocrinol Metab. 2009 Nov;94(11):4524-32. doi: 10.1210/jc.2009-0381. Epub 2009 Oct 9.