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

Obesity Clinical Trial

— VEG-EAT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06152536
• Other study ID #: 04/INT/2022
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: IRCCS San Raffaele
• Contact: Emanuele Bosi, MD
• Phone: 0226432818
• Email: bosi.emanuele[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diet, Healthy
• Obesity

Intervention

Other:
• Vegetarian Meal
"meal with vegetarian protein" and "meal with animal protein"

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milano

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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,