Actively Recruiting
Effects of VLCKD in Metabolic Syndrome
Led by Azienda Ospedaliero Universitaria Maggiore della Carita · Updated on 2024-10-28
40
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
A
Azienda Ospedaliero Universitaria Maggiore della Carita
Lead Sponsor
L
Laboratoire THERASCIENCE
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Effects of VLCKD in Metabolic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 25 to 65 years
- Body mass index (BMI) between 30 and 40 mg/m2
- Diagnosed with non-alcoholic fatty liver disease (NAFLD)
- Treated for type 2 diabetes with medications such as metformin, SGLT2 inhibitors, GLP-1 analogues, DPPIV inhibitors, or basal insulin
- HbA1c level greater than 7% and less than 10%
You will not qualify if you...
- Secondary obesity caused by genetic or hormonal disorders
- Kidney disease with estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73m2, significant protein in urine, or kidney stones
- Using both basal and bolus insulin or HbA1c greater than 10%
- Having other types of diabetes besides type 2
- Having pituitary gland disorders or adrenal insufficiency
- Use of antibiotics less than 3 months before the first study visit
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
: 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, 28100
Actively Recruiting
Research Team
F
Flavia Prdoam, Prof. MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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