Metabolic Effects of Very Low Carbohydrate Ketogenic Diet in Subjects With Severe Obesity
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
- 是
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
Maria Anastasia Ricci
Principal Investigator
University Of Perugia
