Status:
UNKNOWN
Effect of a Vegetarian Meal on the Physiology of Insulin Response in Patients With Type 2 Diabetes Mellitus and Obesity
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Type2diabetes
Obesity
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06152536
Start Date
June 9 2022
End Date
September 30 2024
Last Update
November 30 2023
Active Locations (1)
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1
IRCCS Ospedale San Raffaele
Milan, Italy, 20132