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

NCT03564002 | Unknown

• 1 other identifier: 2017-12
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lysosomal Acid Lipase Deficiency; Obesity; Ketogenic Dieting; Ketosis

Outcome Measures

Primary Outcomes (6)

• 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

• endothelial function

  flow mediated dilation at brachial artery by ultrasonography

  change from baseline after 25 days

• visceral fat

  ultrasonography

  change from baseline after 25 days

• liver steatosis

  ultrasonography

  change from baseline after 25 days

• lipid assessment

  total cholesterol, triglycerides, HDL, LDL

  change from baseline after 25 days

• general adiposity assessment

  bioimpedentiometry

  change from baseline after 25 days

Study Arms (2)

obese subjects

lean subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

obese patients referred to our Clinic in order to assess and treat obesity

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Of Perugia: lead

Study Sites (1)

University of Perugia

Perugia, 06132, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Wolman Disease; Obesity; Ketosis

Condition Hierarchy (Ancestors)

Cholesterol Ester Storage Disease; Lipidoses; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Infant, Newborn, Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Acidosis; Acid-Base Imbalance

Central Study Contacts

Graziana Lupattelli, Professor

CONTACT

+390755784023; graziana.lupattelli@unipg.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2018
• First Posted: June 20, 2018
• Study Start: October 1, 2016
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 9, 2020

Record last verified: 2020-03

Locations

IT (1)