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临床试验/NCT03564002
NCT03564002Unknown不适用

Metabolic Effects of Very Low Carbohydrate Ketogenic Diet in Subjects With Severe Obesity

University Of Perugia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
lysosomal acid lipase activity

研究概览

简要总结

The very low carbohydrates diet (VLCKD) induces liver steatosis amelioration. Lysosomal acid lipase (LAL) deficiency plays a role in fats accumulation in liver. To date, no studies have assessed LAL activity in morbid obesity. The aim of our study is to evaluate VLCKD impact on metabolic/vascular parameters and LAL activity in obese patients.

A VLCKD is administered for 25 days to 52 morbid obese patients (BMI 44.7±8.3 kg/m², age 49±12.5 years); at baseline and after diet we evaluated: BMI, glyco-lipidic pattern, abdominal ultrasonography (liver steatosis and visceral fat area) and flow-mediated dilation (FMD). In a subgroup of 20 patients we also tested lysosomal acid lipase (LAL)-activity. A group of healthy normal weight subjects (age 43±13, BMI 22.8±2.6 kg/m²) was also included in the study.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI > 40 Kg/m2 or > 35 kg/m2 with comorbidities

排除标准

  • Type-2 diabetes
  • Kidney, heart or liver failure

结局指标

主要结局

lysosomal acid lipase activity

时间窗: change from baseline after 25 days

LAL-activity was dosed with dried blood spot (DBS) technique using the inhibitors Lalistat 2

general adiposity assessment

时间窗: change from baseline after 25 days

bioimpedentiometry

endothelial function

时间窗: change from baseline after 25 days

flow mediated dilation at brachial artery by ultrasonography

visceral fat

时间窗: change from baseline after 25 days

ultrasonography

liver steatosis

时间窗: change from baseline after 25 days

ultrasonography

lipid assessment

时间窗: change from baseline after 25 days

total cholesterol, triglycerides, HDL, LDL

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Anastasia Ricci

Principal Investigator

University Of Perugia

研究点 (1)

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