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

Phase 2

Recruiting

• Conditions: acromegaly; healthy

• Registration Number: 2024-518214-11-01
• Lead Sponsor: Medical University Of Vienna

Brief Summary

We aim to define the role of GH action in modifying HCL by regulating hepatic VLDL secretion, DNL and energy metabolism in healthy humans.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Age between 18 – 70 years

for healthy volunteers: Plasma trigylcerides: < 300 mg/dl

for healthy volunteers: male sex

Exclusion Criteria

for healthy volunteers: HbA1c > 6%

for healthy volunteers: 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.

for patients with acromegaly: serum TGs > 500 mg/dl

for patients with acromegaly: severe liver disease (LFTs 3x ULN)

for patients with acromegaly: glomerular filtration rate < 45 mL/min

history of pancreatitis

for healthy volunteers: serum TGs > 300 mg/dl

for healthy volunteers: known liver or kidney disease (AST/ALT > ULN, GFR < 65 ml/min)

for healthy volunteers: consummation of alcoholic beverages during the last 48 hours

for healthy volunteers: Body-Mass-Index > 30 kg/m²

for healthy volunteers: tendency towards claustrophobia

simultaneous participation in another active clinical study

allergies against soy products, eggs, peanuts

Study & Design

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

Primary Outcome Measures

Name	Time	Method
GH induced changes in metabolism of energy rich phosphates (ATP turnover)		GH induced changes in metabolism of energy rich phosphates (ATP turnover)

Secondary Outcome Measures

Name	Time	Method
GH induced changes in hepatic lipid content		GH induced changes in hepatic lipid content
GH induced changes in VLDL secretion		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 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 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 resting energy expenditure
GH induced changes in body composition		GH induced changes in body composition

Trial Locations

Locations (1)

Medical University Of Vienna; 🇦🇹 Vienna, Austria

Medical University Of Vienna

🇦🇹Vienna, Austria

Peter Wolf

Site contact

+4314040043110

Peter.wolf@meduniwien.ac.at