Effects of VLCKD in Metabolic Syndrome (KETO-MI)
Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Obesity
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- : Italy Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediatrics, Department of Health Sciences, University of Eastern PiedmontRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
VLCKD
Hypocaloric Mediterranean Diet
20 Patients recruited from our endocrinology department that will keep the same medical visits frequency and drugs and accept to be randomized to one of the two groups. Inclusion criteria: Age 25-65 BMI 30-40 mg/m2 NAFLD DM2 drug-treated (metformin, SGLT2 inhibitors, GLP-1 analogues, DPPIV inhibitors, insulin) and HbA1c > 7 and < 10 %.
20 Patients recruited from our endocrinology department that will keep the same medical visits frequency and drugs and accept to be randomized to one of the two groups. Inclusion criteria: Age 25-65 BMI 30-40 mg/m2 NAFLD DM2 drug-treated (metformin, SGLT2 inhibitors, GLP-1 analogues, DPPIV inhibitors, insulin) and HbA1c > 7 and < 10 %.