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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03564002

Enrollment

Registered

2018-06-20

Start date

2016-10-01

Completion date

2022-12-31

Last updated

2020-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ketogenic Dieting, Ketosis, Lysosomal Acid Lipase Deficiency, Obesity

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Countries

Italy

Contacts

Primary ContactGraziana Lupattelli, Professor

graziana.lupattelli@unipg.it+390755784023

Outcome results