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

Sponsor

IRCCS San Raffaele (Other)

Overall Status

Recruiting

CT.gov ID

NCT06152536

Collaborator

(none)

Enrollment

Location

Arms

27.7

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Type2diabetes Obesity Diet, Healthy Nutrition, Healthy	Other: Vegetarian Meal	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Monocentric, controlled and randomized trial in crossover.Monocentric, controlled and randomized trial in crossover.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 9, 2022

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

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"

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"

Outcome Measures

Primary Outcome Measures

Physiopathology of glucose after two different meals [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,]
evaluation of glycemic curve after a meal with a vegetarian protein compared to the same evaluation after a meal with an animal protein

Secondary Outcome Measures

Physiopathology of insulin after two different meals [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,]
evaluation of insulin curve after a meal with a vegetarian protein compared to the same evaluation after a meal with an animal protein

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)