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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03564002
• Other study ID #: 2017-12
• Status: Recruiting
• Start date: October 1, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2020
• Source: University Of Perugia
• Contact: Graziana Lupattelli, Professor
• Phone: +390755784023
• Email: graziana.lupattelli[@]unipg.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Type-2 diabetes

• Kidney, heart or liver failure

Related Conditions & MeSH terms

• Ketogenic Dieting
• Ketosis
• Lysosomal Acid Lipase Deficiency
• Obesity
• Obesity, Morbid
• Wolman Disease

Locations

Country	Name	City	State
Italy	University of Perugia	Perugia

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

Country where clinical trial is conducted

Italy, 

Outcome

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