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

University Of Perugia

Status: Unknown

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

Study type: Observational

Funder types: Other

Identifiers

NCT03564002

2017-12

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

60 participants in 2 patient groups

obese subjects

lean subjects