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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meal 2 | Experimental | Meal with a vegetarian protein |
|
| Meal 1 | Active Comparator | Meal with animal protein |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vegetarian Meal | Other | "meal with vegetarian protein" and "meal with animal protein" |
|
| 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, |
| 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, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emanuele Bosi, MD | Contact | 0226432818 | bosi.emanuele@hsr.it | |
| Andrea Pontara | Contact | +393473064605 | pontara.andrea@hsr.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale San Raffaele | Recruiting | Milan | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27851812 | Background | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Monocentric, controlled and randomized trial in crossover.
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |