Impact of a vegetarian meal on insulin response in obese patients with type 2 diabetes
Effect of a Vegetarian Meal on the Pathophysiology of Insulin Response: a Randomized Controlled Crossover Study in Patients With Type 2 Diabetes and Obesity
This study is testing whether eating a vegetarian meal can help improve insulin and blood sugar levels in people with type 2 diabetes and obesity compared to a Mediterranean meal.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milano) |
| Trial ID | NCT06152536 on ClinicalTrials.gov |
What this trial studies
This study evaluates how a vegetarian meal affects insulin and glucose responses compared to a conventional Mediterranean meal in patients with type 2 diabetes and obesity. It involves a randomized crossover design where participants will consume both meal types at least one week apart. Blood tests will be conducted before and after each meal to assess various metabolic parameters. The goal is to determine the potential benefits of vegetarian nutrition in managing diabetes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a diagnosis of type 2 diabetes, a BMI of 30 or greater, and currently managed with diet or metformin.
Not a fit: Patients with significant weight loss recently, those on multiple diabetes medications, or with certain medical conditions like pancreatitis or liver cirrhosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary interventions that improve insulin sensitivity and glucose control in patients with type 2 diabetes.
How similar studies have performed: Previous studies have indicated that vegetarian diets may lower the risk of developing type 2 diabetes, suggesting potential success for this dietary approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-70 years * Diagnosis of T2DM * In treatment with diet alone or single oral drug metformin * BMI ≥ 30 * HbA1c between 6.0 and 9.0% (42-75 mmol/mol) * Signature of the informed consent Exclusion Criteria: * History of acute/chronic pancreatitis * Pancreatic cancer * Pancreatic surgery * Renal failure (any stage) * Liver cirrhosis * Thyroid disorders (hypothyroidism, hyperthyroidism) * Patients with weight loss in the last 3 months equal to or greater than 5% of body weight * Patients on therapy other than metformin monotherapy (insulin, glucagon-like peptide agonists, sulphonylureas, glitazones, dipeptidyl peptidase inhibitors, SGLT2 inhibitors). * Pregnant or breastfeeding women * History of severe allergic reaction to any food (anaphylaxis)
Where this trial is running
Milano
- IRCCS Ospedale San Raffaele — Milano, Italy (Recruiting)
Study contacts
- Study coordinator: Emanuele Bosi, MD
- Email: bosi.emanuele@hsr.it
- Phone: 0226432818
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.