Study on Mechanisms of Changes in Liver Disease and Sex Steroid Metabolism During Weight Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change from baseline in sex steroids
研究概览
简要总结
The main objective of the study is to gain insight in the early dynamics and mechanisms of recovery of liver disease and sex steroid metabolism during weight loss in obese men and women and to investigate whether surgical weight loss has differential effects as compared to weight loss with life style measures. In addition, we want to evaluate the postprandial hypoglycemic reactive syndrome (PPHRS) in these patients using a standard chewable meal.
Secondary objectives are investigating determinants for the changes in sex steroids, liver disease and PPHRS. Possible determinants to be investigated are adipocytokine secretion patterns, body composition, resting metabolism rate, weight loss per se and changes in fat distribution, parameters of fatty acid metabolism, ... .
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained
- •BMI > 35 kg/m²
排除标准
- •Primary or secondary hypogonadism due to genetic causes (Kallman syndrome etc.), tumors, infiltrative diseases, infections, pituitary apoplexy, trauma, critical illness, chronic systemic illness or intentional.
- •Type 2 Diabetes Mellitus treated with insulin or GLP-1 analogues
- •Current or recent use of insulin, corticosteroids, opiates (on a daily basis), growth hormones, androgen- or estrogen analogs, levothyroxine, anti-retroviral drugs or antipsychotics
- •Cancer (within < 5 years)
- •High-grade malignancies
- •Serious co-morbidities such as renal, hepatic of cardiac failure
- •Known or suspected abuse of alcohol or narcotics
- •Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation.
结局指标
主要结局
Change from baseline in sex steroids
时间窗: Baseline, 3 weeks, 6 weeks, 6 months, 1 year.
The change in sex steroids will be compared between the conservative and the gastric bypass group.
Change from baseline in liver fat
时间窗: Baseline, 6 months, 1 year
The change in liver steatose will be compared between the conservative and the gastric bypass group
Correlation in changes in liver fat en changes in sex steroids
时间窗: baseline, 6 months, 1 year
次要结局
未报告次要终点