2024-518214-11-01招募中2 期
InvestiGating the rOle of Growth Hormone in hepatic lipid metabolism in humans
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- GH induced changes in metabolism of energy rich phosphates (ATP turnover)
研究概览
简要总结
We aim to define the role of GH action in modifying HCL by regulating hepatic VLDL secretion, DNL and energy metabolism in healthy humans.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age between 18 – 70 years
- •for healthy volunteers: Plasma trigylcerides: < 300 mg/dl
- •for healthy volunteers: male sex
排除标准
- •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
结局指标
主要结局
GH induced changes in metabolism of energy rich phosphates (ATP turnover)
GH induced changes in metabolism of energy rich phosphates (ATP turnover)
次要结局
- 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
研究者
Department of Medicine III, Division of Endocrinology and Metabolism
Scientific
Medical University Of Vienna
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Growth hormone deficiency and clottingISRCTN59234325eeds Teaching Hospitals NHS Trust (UK)140
招募中
不适用
Determination of growth hormone and related peptides in serum and plasmaJPRN-jRCTs031220120Furihata Kenichi6
尚未招募
3 期
Investigating the results of adding growth hormone to the ovulation stimulation regimen in microinjection and In Vitro Fertilization in patients with low ovarian reserveIRCT20130603013566N13Vice chancellor for Research,Tabriz University Of Medical Sciences96
终止
不适用
Growth Hormone testing after stroke (GROWTH)StrokeACTRN12615000701527John Hunter Hospital60
进行中（未招募）
不适用
A study to determine the effects of growth hormone (GH) replacement therapy on quality of life and cardiovascualr risk in GH deficient adults - Growth Hormone and Quality of Life (GroH-QoL)EUCTR2004-004835-72-GBniversity of Birmingham200