Lysosomal Acid Lipase Increase After Chetogenic Diet.
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|ClinicalTrials.gov Identifier: NCT03564002|
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : June 21, 2018
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.
|Condition or disease|
|Lysosomal Acid Lipase Deficiency Obesity Ketogenic Dieting Ketosis|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Actual Study Start Date :||October 1, 2016|
|Actual Primary Completion Date :||December 31, 2017|
|Estimated Study Completion Date :||April 30, 2019|
- lysosomal acid lipase activity [ Time Frame: change from baseline after 25 days ]LAL-activity was dosed with dried blood spot (DBS) technique using the inhibitors Lalistat 2
- endothelial function [ Time Frame: change from baseline after 25 days ]flow mediated dilation at brachial artery by ultrasonography
- visceral fat [ Time Frame: change from baseline after 25 days ]ultrasonography
- liver steatosis [ Time Frame: change from baseline after 25 days ]ultrasonography
- lipid assessment [ Time Frame: change from baseline after 25 days ]total cholesterol, triglycerides, HDL, LDL
- general adiposity assessment [ Time Frame: change from baseline after 25 days ]bioimpedentiometry
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564002
|Contact: Graziana Lupattelli, Professorfirstname.lastname@example.org|
|University of Perugia||Recruiting|
|Perugia, Italy, 06132|
|Contact: Graziana Lupattelli, Prof +390755784023 email@example.com|