Effects of VLCKD in Metabolic Syndrome (KETO-MI)

University Hospital Maggiore della Carità of Novara

Status: Enrolling

Conditions: Obesity; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2; Metabolic Syndrome

Treatments: Behavioral: Hypocaloric mediterranean Diet; Dietary Supplement: VLCKD diet with replacing meals

Study type: Interventional

Funder types: Other

Identifiers

NCT05275608

CE 296/21

Details and patient eligibility

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

VLCKD

Experimental group

Description:

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 %.

Treatment:

Dietary Supplement: VLCKD diet with replacing meals

Hypocaloric Mediterranean Diet

Active Comparator group

Description:

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 %.

Treatment:

Behavioral: Hypocaloric mediterranean Diet