InvestiGating the rOle of Growth Hormone in hepatic lipid metabolism in humans

Phase 1

• Conditions: Healthy subjects; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2020-000831-34-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-07
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

+ Age between 18 – 70 years
+ Plasma trigylcerides: < 300 mg/dl
+ male sex

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

+ HbA1c > 6%
+ history of pancreatitis
+ serum TGs > 300 mg/dl
+ known liver or kidney disease (AST/ALT > ULN, GFR < 65 ml/min)
+ consummation of alcoholic beverages during the last 48 hours
+ body-Mass-Index > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): •GH induced changes in hepatic lipid content<br>•GH induced changes in VLDL secretion<br>•GH induced changes in de novo lipogenesis, i.e. the incorporation of D2 into VLDL-TG palmitate and lipid profiling using a DNL index<br>•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<br>•GH induced changes in resting energy expenditure<br>•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