Effect of a Vegetarian Meal on the Pathophysiology of Insulin Response: a Randomized Controlled Crossover Study in Patients With Type 2 Diabetes and Obesity
Effect of a Vegetarian Meal on the Physiology of Insulin Response in Patients With Type 2 Diabetes Mellitus and Obesity
Sponsors
Source
IRCCS San Raffaele
Oversight Info
Has Dmc
Yes
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
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).
Overall Status
Recruiting
Start Date
2022-06-09
Completion Date
2024-09-30
Primary Completion Date
2024-09-30
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
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, |
Secondary Outcome
Measure |
Time Frame |
|
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, |
Enrollment
20
Conditions
Intervention
Intervention Type
Other
Intervention Name
Description
"meal with vegetarian protein" and "meal with animal protein"
Arm Group Label
Meal 1
Meal 2
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)
Gender
All
Minimum Age
18 Years
Maximum Age
70 Years
Healthy Volunteers
No
Overall Contact
Last Name
Emanuele Bosi, MD
Phone
0226432818
bosi.emanuele@hsr.it
Location
Facility |
Status |
Contact |
|
IRCCS Ospedale San Raffaele Milan 6951411 20132 Italy |
Recruiting |
Last Name: Emanuele Bosi, Professor Phone: 00390226432821 Email: bosi.emanuele@hsr.it |
Location Countries
Country
Italy
Verification Date
2023-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
IRCCS San Raffaele
Investigator Full Name
Emanuele Bosi
Investigator Title
Professor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
Meal 2
Arm Group Type
Experimental
Description
Meal with a vegetarian protein
Arm Group Label
Meal 1
Arm Group Type
Active Comparator
Description
Meal with animal protein
Firstreceived Results Date
N/A
Overall Contact Backup
Last Name
Andrea Pontara
Phone
+393473064605
pontara.andrea@hsr.it
Reference
Citation
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.
PMID
27851812
Acronym
VEG-EAT
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Monocentric, controlled and randomized trial in crossover.
Primary Purpose
Prevention
Masking
None (Open Label)
Study First Submitted
February 14, 2023
Study First Submitted Qc
November 28, 2023
Study First Posted
November 30, 2023
Last Update Submitted
November 28, 2023
Last Update Submitted Qc
November 28, 2023
Last Update Posted
November 30, 2023
ClinicalTrials.gov processed this data on October 31, 2025
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.