The Effect of Growth Hormone (GH) on Intramyocellular Lipids (IMCL), Intrahepatocellular Lipids (IHCL) and Visceral Fat Mass in Relation to Insulin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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
详细描述
Using the two-step hyperinsulinaemic-euglycaemic clamp technique hepatic and peripheral insulin sensitivity is assessed.
Lipid depots (skeletal muscle and liver) are measured by MR-spectroscopy, visceral fat mass by MR-imaging.
Exercise capacity ist measured on a treadmill. Counterregulatory hormones, glucose and free fatty acids are measured during a 2h physical exercise at 50-60 VO2max Identical investigations are performed in adult growth hormone (GH) deficient patients before and after six months GH replacement therapy, in sedentary matched control subjects and in endurance trained athletes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Athletes, controls, patients
Sedentary controls: age, BMI, Gender and waist matched (to the growth hormone deficient patients) healthy control subjects Endurance trained athletes: minimal >50 mlO2/KG body weight
干预措施: Growth hormone replacement therapy in growth hormone deficient patients only. (Drug)
结局指标
主要结局
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
时间窗: 2008 - 2009
次要结局
- maximal exercise capacity(2008 - 2009)
- Measurement of serum alphaKlothe by an ELISA(2008 - 2013)
研究者
Emanuel Christ
Prof. Emanuel Christ, MD, PhD
Insel Gruppe AG, University Hospital Bern