Impact of a Very Low-Calorie Ketogenic Diet on Metabolic Syndrome
Effects of Very Low Calorie Ketogenic Diet on Microbiota, Adipose Tissue and Immunitary Regulation: Pilot Study on Patients with Metabolic Syndrome
This study is testing whether a Very Low-Calorie Ketogenic Diet can help people with Type 2 diabetes, obesity, and fatty liver disease improve their health compared to a Mediterranean diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliero Universitaria Maggiore della Carita Academic / other |
| Locations | 1 site (Novara, Italy) |
| Trial ID | NCT05275608 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of a Very Low-Calorie Ketogenic Diet (VLCKD) on patients with Type 2 Diabetes Mellitus, obesity, and Non-Alcoholic Fatty Liver Disease (NAFLD). It compares the VLCKD to a hypocaloric Mediterranean diet, assessing various outcomes including anthropometric data, biochemical parameters, and microbiota analysis. The study will involve 40 participants divided into two groups, each receiving one of the dietary interventions. The goal is to evaluate the potential benefits of VLCKD in improving metabolic health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25-65 with a BMI between 30-40, diagnosed with Type 2 Diabetes Mellitus and NAFLD.
Not a fit: Patients with secondary obesity due to genetic or endocrinologic causes or those with severe renal disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary approach for managing metabolic syndrome and its associated conditions.
How similar studies have performed: Previous studies have shown promising results for VLCKD in managing metabolic conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Novara, Italy
- : 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 (Recruiting)
Study contacts
- Study coordinator: Flavia Prdoam, Prof. MD
- Email: flavia.prodam@med.uniupo.it
- Phone: +39 0321 660 693
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.