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

Last updated: March 5, 2020
Sponsor: University Of Perugia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Wolman Disease

Treatment

N/A

Clinical Study ID

NCT03564002
2017-12
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Type-2 diabetes

  • Kidney, heart or liver failure

Study Design

Total Participants: 60
Study Start date:
October 01, 2016
Estimated Completion Date:
December 31, 2022

Connect with a study center

  • University of Perugia

    Perugia, 06132
    Italy

    Active - Recruiting

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