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

• Conditions: Ketosis; Lysosomal Acid Lipase Deficiency; Obesity; Ketogenic Dieting

• Registration Number: NCT03564002
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2018-05-26
• Study First Submitted QC: 2018-06-08
• Study First Posted: 2018-06-20
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-05
• Last Update Posted: 2020-03-09
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
lysosomal acid lipase activity	change from baseline after 25 days	LAL-activity was dosed with dried blood spot (DBS) technique using the inhibitors Lalistat 2
general adiposity assessment	change from baseline after 25 days	bioimpedentiometry
endothelial function	change from baseline after 25 days	flow mediated dilation at brachial artery by ultrasonography
visceral fat	change from baseline after 25 days	ultrasonography
liver steatosis	change from baseline after 25 days	ultrasonography
lipid assessment	change from baseline after 25 days	total cholesterol, triglycerides, HDL, LDL

Trial Locations

Locations (1)

University of Perugia; 🇮🇹 Perugia, Italy