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Trial record 73 of 93 for:    Recruiting, Not yet recruiting, Available Studies | "Cholesterol"

Lysosomal Acid Lipase Increase After Chetogenic Diet.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03564002
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : June 21, 2018
Information provided by (Responsible Party):
Maria Anastasia Ricci, University Of Perugia

Brief 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.

Condition or disease
Lysosomal Acid Lipase Deficiency Obesity Ketogenic Dieting Ketosis

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : December 31, 2017
Estimated Study Completion Date : April 30, 2019

obese subjects
lean subjects

Primary Outcome Measures :
  1. 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

  2. endothelial function [ Time Frame: change from baseline after 25 days ]
    flow mediated dilation at brachial artery by ultrasonography

  3. visceral fat [ Time Frame: change from baseline after 25 days ]

  4. liver steatosis [ Time Frame: change from baseline after 25 days ]

  5. lipid assessment [ Time Frame: change from baseline after 25 days ]
    total cholesterol, triglycerides, HDL, LDL

  6. general adiposity assessment [ Time Frame: change from baseline after 25 days ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
obese patients referred to our Clinic in order to assess and treat obesity

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03564002

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Contact: Graziana Lupattelli, Professor +390755784023

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University of Perugia Recruiting
Perugia, Italy, 06132
Contact: Graziana Lupattelli, Prof    +390755784023   
Sponsors and Collaborators
University Of Perugia

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Responsible Party: Maria Anastasia Ricci, Principal Investigator, University Of Perugia Identifier: NCT03564002     History of Changes
Other Study ID Numbers: 2017-12
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wolman Disease
Metabolic Diseases
Cholesterol Ester Storage Disease
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lysosomal Storage Diseases
Infant, Newborn, Diseases
Lipid Metabolism Disorders