Effects of VLCKD in Metabolic Syndrome

ConditionsDiabetes Mellitus, Type 2 Non-alcoholic Fatty Liver Disease Obesity Metabolic Syndrome

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age25-65

SponsorAzienda Ospedaliero Universitaria Maggiore della Carita

About this trial

VLCKD has showed to be an impactful diet on several metabolism aspects and has proven to be useful for preventing and treating diabetes mellitus type 2, overweight, chronic inflammation and fatty liver.

For this reason, the aim of this pilot study is to examinate the potential effect of a VLCKD on a group of patients that contemporarily have DM2, obesity and Non alcholic fatty liver disease (NAFLD), comparing the results with an ipocaloric diet based on Mediterranean Principles and Italian LARN (SINU 2014).

This study will consider several interrelated outcomes such as anthropometric data, hematochemical and hormonal parameters, questionnaires, stool microbiota and omics, blood microvescicles, urine tests, instrumental tests (DXA, BIVA, ecographies), biopses and functional tests.

40 subjects will be evaluated and divided in two groups of 20 (VLCKD) and 20 (MedDiet).

Eligibility criteria

Qualifiers

Age 25-65

BMI 30-40 mg/m2

NAFLD

DM2 drug-treated (metformin, SGLT2 inhibitors, GLP-1 analogues, DPPIV inhibitors, basal insulin) and HbA1c > 7 and < 10 %.

Disqualifiers

Secondary obesity due to genetic or endocrinologic causes.

renal disease with eGFR < 45 mL/min/1.73m2 or macroalbuminuria or calculosis

insulin basal + bolus or HbA1c% >10.0%

Other types of DM

Trial design

Treatments tested in this trial

VLCKD diet with replacing meals
Hypocaloric mediterranean Diet

Treatment groups

40 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Azienda Ospedaliero Universitaria Maggiore della Carita

Lead sponsor

Laboratoire THERASCIENCE

Collaborator

Source ClinicalTrials.gov