Condition: Diabetes Mellitus, Type 2 · Non-alcoholic Fatty Liver Disease · Obesity · Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
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).
This description comes directly from the study's public registry record.
Flavia Prdoam, Prof. MD · +39 0321 660 693 · flavia.prodam@med.uniupo.it
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| : Italy Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediatrics, Department of Health Sciences, University of Eastern Piedmont | Novara, Italy, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05275608