Clinical Trial

Effects of VLCKD in Metabolic Syndrome

Study acronym: KETO-MI

Recruiting

Record status

This record was last updated October 28, 2024 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.

Summary

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).

Protocol Amendment History 4 amendments

This ClinicalTrials.gov record has been amended 4 times since 2022-03-02; most recent amendment 2024-10-24.

Status change: Not Yet Recruiting → Recruiting 2022-04-06

Trial Details

NCT Number	NCT05275608
Lead Sponsor	Azienda Ospedaliero Universitaria Maggiore della Carita Collaborators: Laboratoire THERASCIENCE
Conditions	Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Obesity, Metabolic Syndrome
Enrollment	40 participants
Start Date	2022-11-07
Primary Completion	2025-09 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2024-10-28