Healthy subjects
Conditions
Interventions
Trade Name: Genotropin
Product Name: Genotropin
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Somatropin
Other descriptive name: recombinant growth hormone
Co
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: + Age between 18 – 70 years + Plasma trigylcerides: =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: + HbA1c > 6% + history of pancreatitis + serum TGs > 300 mg/dl + known liver or kidney disease (AST/ALT > ULN, GFR 30 kg/m² + tendency towards claustrophobia + simultaneous participation in another active clinical study + allergies against soy products, eggs, peanuts + metal devices or other magnetic material in or on the subjects body which will be hazardous for NMR investigation [heart pacemaker, coronary stents and heart valves (in case these devices are not compatible with a 7T MT), brain (aneurysm) clip, nerve stimulators, electrodes, ear implants, penile implants, colored contact lenses, patch to deliver medications through the skin, vascular filter for blood clots, orthodontic braces, shunt-spinal or ventricular, any metal implants (rods, joints, plates, pins, screws, nails, or clips), embolization coil, or any metal fragments or shrapnel in the body.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We aim to define the role of GH action in modifying HCL by regulating hepatic VLDL secretion, DNL and energy metabolism in healthy humans.;Secondary Objective: We aim to trace D2 enrichments in lipids in liver and adipose tissue by high resolution magnetic resonance spectroscopy (MRS).;Primary end point(s): • GH induced changes in hepatic ATP Turnover;Timepoint(s) of evaluation of this end point: At baseline and 7 days after administration of genotropin or somavert | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • GH induced changes in hepatic lipid content • GH induced changes in VLDL secretion • GH induced changes in de novo lipogenesis, i.e. the incorporation of D2 into VLDL-TG palmitate and lipid profiling using a DNL index • GH induced changes in the accumulation of deuterium label in lipid stores, including liver and subcutaneous adipose tissue, as measure of depot specific de novo lipogenesis • GH induced changes in resting energy expenditure • GH induced changes in body composition;Timepoint(s) of evaluation of this end point: At baseline and 7 days after administration of genotropin or somavert | — |
Countries
Austria
Contacts
Public ContactDivision of Endocrinology
Medical University of Vienna
Outcome results
None listed