Effects of VLCKD in Metabolic Syndrome

Launched by AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARITA · Mar 2, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of a Very Low Calorie Ketogenic Diet (VLCKD) on patients who have diabetes type 2, obesity, and non-alcoholic fatty liver disease (NAFLD). The goal is to see if this specific diet can help improve their health compared to a Mediterranean diet, which is known for its focus on healthy eating. Researchers will look at various health factors, such as body measurements, blood tests, and other health assessments, to understand how each diet affects the participants.

To participate in this study, individuals must be between the ages of 25 and 65, have a body mass index (BMI) between 30 and 40, and be treated for diabetes with certain medications. Participants will be divided into two groups, with one group following the VLCKD and the other following the Mediterranean diet. This is a great opportunity for eligible individuals to contribute to research that may lead to better dietary options for managing diabetes and related health issues.

Gender

ALL

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