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

NCT ID: NCT06152536

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-09

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Type2diabetes Obesity Diet, Healthy Nutrition, Healthy

Keywords

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nutrition meal insulin glycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Monocentric, controlled and randomized trial in crossover.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Meal 2

Meal with a vegetarian protein

Group Type EXPERIMENTAL

Vegetarian Meal

Intervention Type OTHER

"meal with vegetarian protein" and "meal with animal protein"

Meal 1

Meal with animal protein

Group Type ACTIVE_COMPARATOR

Vegetarian Meal

Intervention Type OTHER

"meal with vegetarian protein" and "meal with animal protein"

Interventions

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Vegetarian Meal

"meal with vegetarian protein" and "meal with animal protein"

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Emanuele Bosi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Emanuele Bosi, MD

Role: CONTACT

Phone: 0226432818

Email: [email protected]

Andrea Pontara

Role: CONTACT

Phone: +393473064605

Email: [email protected]

Facility Contacts

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Emanuele Bosi, Professor

Role: primary

Patrizia Rovere Querini, Professor

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 27851812 (View on PubMed)

Other Identifiers

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04/INT/2022

Identifier Type: -

Identifier Source: org_study_id