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

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clinicaltrials.gov/study/NCT03564002
Is a
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Clinical study
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Clinical Study attributes

NCT Number
NCT035640020
Health Conditions in Trial
Lysosomal acid lipase deficiency
Lysosomal acid lipase deficiency
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Ketosis
Ketosis
0
Obesity
Obesity
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Trial Recruitment Size
600
Trial Sponsor
University of Perugia
University of Perugia
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Clinical Trial Start Date
October 1, 2016
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Primary Completion Date
December 31, 2022
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Study Completion Date
December 31, 2022
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Clinical Trial Study Type
Observational0
Observational Clinical Trial Type
Case-Control0
Observational Study Perspective
Prospective0
Participating Facility
University of Perugia
University of Perugia
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Official Name
Metabolic Effects of Very Low Carbohydrate Ketogenic Diet in Subjects With Severe Obesity0
Last Updated
March 9, 2020
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Study summary

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.

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