NCT03564002

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: University Of Perugia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lysosomal Acid Lipase Deficiency
• Obesity
• Ketogenic Dieting
• Ketosis

Timeline

• Start date: 2016-10-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2018-06-20
• Last updated: 2020-03-09

Locations

1 site across 1 country: Italy