Status:
RECRUITING
Effects of VLCKD in Metabolic Syndrome
Lead Sponsor:
Azienda Ospedaliero Universitaria Maggiore della Carita
Collaborating Sponsors:
Laboratoire THERASCIENCE
Conditions:
Diabetes Mellitus, Type 2
Non-alcoholic Fatty Liver Disease
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief 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 live...
Eligibility Criteria
Inclusion
- 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 %.
Exclusion
- 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
- ipopituitarism or adrenal insufficiency
- antibiotics use less than 3 months before the first visit
Key Trial Info
Start Date :
November 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05275608
Start Date
November 7 2022
End Date
December 1 2025
Last Update
October 28 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
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