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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
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
-
-
-
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
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Meal 2
Meal with a vegetarian protein
|
"meal with vegetarian protein" and "meal with animal protein"
|
|
Active Comparator: Meal 1
Meal with animal protein
|
"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
Time Frame: 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
|
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
Time Frame: 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
|
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04/INT/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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