Effect of a Vegetarian Meal on the Physiology of Insulin Response in Patients With Type 2 Diabetes Mellitus and Obesity (VEG-EAT)

Effect of a Vegetarian Meal on the Pathophysiology of Insulin Response: a Randomized Controlled Crossover Study in Patients With Type 2 Diabetes and Obesity

The role of diet in determining glucose intolerance and its progression towards T2DM has been extensively investigated. A 2017 meta-analysis showed that a vegetarian diet is inversely associated with the risk of developing diabetes. Vegetarians, with the same baseline risk, are half as likely to develop T2DM than those following an omnivorous diet. Therefore, vegetarian nutrition could have important clinical implications in the dietary management of diabetic patients.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Diet, Healthy; Nutrition, Healthy; Type2diabetes
• Intervention / Treatment: Other: Vegetarian Meal

Detailed Description

The primary objective of the study is to evaluate the effect of two different isocaloric meals, one vegetarian compared to a conventional Mediterranean-type one (vegetable protein source in the first case and animal in the second case), eaten at lunch, 1÷3 weeks apart, on the pathophysiology of glucose and insulin response. The two meals were elaborated in such a way as to have a superimposable composition.

Study population: 20 patients diagnosed with T2DM and BMI ≥ 30, belonging to the Diabetes and Clinical Nutrition clinic of the IRCCS San Raffaele Hospital.

Study design: single-center, interventional, controlled, randomized crossover.

Procedures: the patients enrolled in the study, for each of the two meals, underwent serial blood tests, before eating lunch (T0) and every 30 minutes, up to 3 hours after the end of the meal itself (T2÷T6).

Collected variables: blood sugar, insulin, c-peptide, HbA1c, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, height, weight, waist circumference and blood pressure, visual analogue scale (0-10) for sense of hunger and satiety , meal satisfaction index (0-10).

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emanuele Bosi, MD; Phone Number: 0226432818; Email: bosi.emanuele@hsr.it
• Study Contact Backup: Name: Andrea Pontara; Phone Number: +393473064605; Email: pontara.andrea@hsr.it

Study Locations

• Italy
  • Milano, Italy, 20132
    • Recruiting
    • IRCCS Ospedale San Raffaele
    • Contact: Emanuele Bosi, Professor; Phone Number: 00390226432821; Email: bosi.emanuele@hsr.it
    • Contact: Patrizia Rovere Querini, Professor; Phone Number: 00390226426768; Email: rovere.patrizia@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meal 2; Meal with a vegetarian protein	Other: Vegetarian Meal; "meal with vegetarian protein" and "meal with animal protein"
Active Comparator: Meal 1; Meal with animal protein	Other: Vegetarian Meal; "meal with vegetarian protein" and "meal with animal protein"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiopathology of glucose after two different meals	evaluation of glycemic curve after a meal with a vegetarian protein compared to the same evaluation after a meal with an animal protein	fasting, 30 minutes after meal, 60 minutes after meal, 90 minutes after meal, 120 minutes after meal, 150 minutes after meal, 180 minutes after meal,

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiopathology of insulin after two different meals	evaluation of insulin curve after a meal with a vegetarian protein compared to the same evaluation after a meal with an animal protein	fasting, 30 minutes after meal, 60 minutes after meal, 90 minutes after meal, 120 minutes after meal, 150 minutes after meal, 180 minutes after meal,

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Publications and helpful links

General Publications

• Fizelova M, Jauhiainen R, Stancakova A, Kuusisto J, Laakso M. Finnish Diabetes Risk Score Is Associated with Impaired Insulin Secretion and Insulin Sensitivity, Drug-Treated Hypertension and Cardiovascular Disease: A Follow-Up Study of the METSIM Cohort. PLoS One. 2016 Nov 16;11(11):e0166584. doi: 10.1371/journal.pone.0166584. eCollection 2016.

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2022
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: nutrition; insulin; meal; glycemia
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity
• Other Study ID Numbers: 04/INT/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No