NCT06152536

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2023

Completed
10 months until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

2.3 years

First QC Date

February 14, 2023

Last Update Submit

November 28, 2023

Conditions

Type2diabetesObesityDiet, HealthyNutrition, Healthy

Keywords

nutritionmealinsulinglycemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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,

Study Arms (2)

Meal 2

EXPERIMENTAL

Meal with a vegetarian protein

Other: Vegetarian Meal

Meal 1

ACTIVE COMPARATOR

Meal with animal protein

Other: Vegetarian Meal

Interventions

Vegetarian MealOTHER

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

Meal 1Meal 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Related 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.

    PMID: 27851812BACKGROUND

MeSH Terms

Conditions

ObesityInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Central Study Contacts

Emanuele Bosi, MD

CONTACT

0226432818bosi.emanuele@hsr.it

Andrea Pontara

CONTACT

+393473064605pontara.andrea@hsr.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Monocentric, controlled and randomized trial in crossover.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 14, 2023

First Posted

November 30, 2023

Study Start

June 9, 2022

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)