Metabolic Effects of Very Low Carbohydrate Ketogenic Diet... | NCT03564002

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

NCT03564002

Sponsor

University Of Perugia

Status

Unknown status

Last Update Posted

Mar 9, 2020Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Lysosomal Acid Lipase Deficiency
Obesity
Ketogenic Dieting
Ketosis

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2016Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

May 26, 2018

First Submission Date that Met QC Criteria

Jun 8, 2018

First Posted Date

Jun 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2020

Last Update Posted Date

Mar 9, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maria Anastasia Ricci, Principal Investigator, University Of PerugiaPrincipal Investigator

Lead Sponsor

University Of PerugiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Type-2 diabetes
Kidney, heart or liver failure

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Graziana Lupattelli, Professor	Contact	+390755784023		graziana.lupattelli@unipg.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Perugia	Recruiting	Perugia		06132	Italy

Condition Browse Module

MeSH Terms

ID	Term
D015223	Wolman Disease
D009765	Obesity
D007662	Ketosis

Ancestor Terms

ID	Term
D015217	Cholesterol Ester Storage Disease
D008064	Lipidoses
D008052	Lipid Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
obese subjects
lean subjects