Effect of a Vegetarian Meal on the Physiology of Insulin Response in Patients With Type 2 Diabetes Mellitus and Obesity

Launched by IRCCS SAN RAFFAELE · Nov 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how eating a vegetarian meal affects insulin response in patients with type 2 diabetes and obesity. Insulin is a hormone that helps control blood sugar levels, and researchers want to see if a vegetarian diet can improve how the body responds to insulin. Previous studies suggest that people who follow a vegetarian diet may have a lower risk of developing diabetes, so this trial aims to explore that idea further.

To participate in this trial, individuals need to be between 18 and 70 years old, diagnosed with type 2 diabetes, and currently managing their condition with diet or a single medication called metformin. They should have a body mass index (BMI) of 30 or higher and specific blood sugar levels. Participants can expect to follow a vegetarian meal plan and provide feedback on their experiences. It’s important to note that some people may not qualify, such as those with certain health conditions or who are on multiple diabetes medications. This study is currently recruiting participants, and it could provide valuable insights into dietary choices for managing diabetes.

Gender

ALL

Eligibility 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)