Growth Hormone Deficiency Clinical Trial
Official title:
The Effect of Growth Hormone (GH) on Intramyocellular Lipids (IMCL), Intrahepatocellular Lipids (IHCL) and Visceral Fat Mass in Relation to Insulin Resistance
This study aims at investigating the effect of growth hormone on lipid-content of muscle and
liver as well as visceral fat mass in relation to insulin sensitivity.
In addition, hormonal regulation and free fatty availability is assessed during a physical
exercise at 50-60% VO2max.
Finally, the value of physical exercise in diagnosing growth hormone deficiency is
investigated.
Hypothesis: 1) Lipid content of muscle and liver change with physical exercise and exercise
capacity and free fatty availability will influence these changes. 2)Growth hormone
replacement therapy will predominantly reduce visceral fat mass and increase free fatty
availability.
3)Free fatty availability during exercise will be reduced in growth hormone deficient
patients 4)Physical exercise may be an alternative way to diagnose growth hormone deficiency
Status | Completed |
Enrollment | 34 |
Est. completion date | June 2013 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Male and female patients with proven GH-deficiency defined as a peak GH of less than 3mU/l during an insulin provocation test with nadir plasma glucose less than 2.2 mmol/l and additionally, stable conventional replacement therapy including corticoids, thyroxin and gonadal hormones as needed. - Ability to perform an exercise test on a treadmill or a walking band. - Willingness to participate in the study and to give written informed consent. Exclusion Criteria: Active neoplasia - Severe cardiovascular disease (unstable coronary heart disease, heart failure NYHA III-IV) - Type 2 Diabetes mellitus - Haemophilia or other coagulation disorder - Inability to exercise - Contraindications to exposure to a 3-T magnetic field (Pace-Makers, osteosynthetic material) - Pregnant women - Women in childbearing age unless on a continuous contraceptive therapy or surgically sterilised. - Abnormal liver or renal function (Creatinine >130mmol/L, normal reference 45-93mmol/L; ASAT and ALAT > 3 times the upper reference limit). - Major depression, psychosis and other severe personality disorders - Excessive alcohol consumption (>60g/d) or drug-abuse - Refusal to give written consent - Patients, who are not suitable for the study according to the study physician |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Switzerland | Abt. für Endokrinologie, Diabetologie und Klin. Ernährung, Inselspital | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne | Swiss National Science Foundation |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determination of visceral fat mass by MRI,Determination of IMCL and IHCL by MR Spectroscopy, Determination of peripheral and hepatic insulin sensitivity by two step hyperinsulinemic euglycemic clamp | 2008 - 2009 | No | |
Secondary | maximal exercise capacity | 2008 - 2009 | No | |
Secondary | Measurement of serum alphaKlothe by an ELISA | Measured in pg/mL | 2008 - 2013 | No |
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