Cardio-metabolic and Inflammatory Impact of Starch Digestibility in Type 2 Diabetic Patients

This is an interventional prevention trial for Type2 Diabetes focused on measuring Slowly Digestible Starch, SDS, Type 2 diabetes, T2D, Glycemic response, Continuous Glucose Monitoring System, CGMS, Diet, MAGE, Mean Amplitude of Glucose Excursion Read More

Inclusion Criteria:

• Patient able to understand the study information and providing written consent for his/her participation to the study
• Male or female
• Patient undergoing medical examination during the selection visit
• Patient aged between 18 and 75 years old (bounds included)
• T2D volunteer with HbA1c between 7% and 8,5% without signs of insulinopenia according to the investigator
• Patient with BMI ranging between 25 and 40 kg/m2 (bounds included)
• Patient with stable body weight over the past three months (+/- 5 % of body weight)
• Patient accepting to change its diet for three months
• Patient not suffering from food intolerance or allergy
• Patient regularly consuming products proposed in the study
• Patient agreeing to consume 3 main meals per day without extra-prandial carbohydrates intakes
• Sedentary behavior or stable predicted physical activity during the study
• Patient not presenting any disease during the medical examination / interview which could interfere with the results of the study according to the investigator
• Patient covered by health insurance
• Patient accepting to have short nails on his/her 2 forefingers

Exclusion Criteria:

• Patient under legal protection measure
• Patient deprived of liberty by a court or an administrative decision
• Patient currently participating in another study or being in the exclusion period of another study
• Volunteer that exceed the financial compensation allowed per year for participating in research programs
• Gamma-GT > 2.5 times above the norm (>160 UI/L)
• ASAT > 2.5 times above the norm (>85 UI/L)
• ALAT > 2.5 times above the norm (>137.5 UI/L)
• Triglycerides > 4 g/L
• LDL-cholesterol > 1.90 g/L
• CRP > 15 mg/L
• Hemoglobin < 120 mg/dL
• eGRF (estimated glomerular filtration rate) < 45 ml/min
• Other biological abnormality with clinical significant relevance according to the investigator
• Patient with type 1 diabetes, post pancreatectomy or post transplant diabetes, MODY diabetes, mitochondrial diabetes, iatrogenic diabetes
• T2D volunteer with any other anti-diabetic treatment other than metformin: insulin therapy, GLP-1 analogues, acarbose, sulphonylureas, repaglinide, SGLT2 agonists,…
• Patient consuming in the two previous months regularly corticoids, beta-blocking drugs or immunosuppressing drugs
• Patient with hemoglobin pathology
• Patient with medical history of hemoglobinopathies (thalassemia, drepanocytosis…)
• Patient with past bariatric surgery
• Patient with medical history of endocrine diseases who may interfere with glucose metabolism according to the investigator (such as hyperthyroidism, acromegaly, hypercorticism…)
• Patient treated with anticoagulants
• Patient with a pace-maker
• Uncontrolled high blood pressure defined by Systolic blood pressure > 150 mmHg or Diastolic blood pressure > 100 mmHg
• Evidence of any other unstable or untreated clinically significant immunological, neoplasic, endocrine, haematological, gastrointestinal, hepatic, neurological or psychiatric abnormalities or medical disease with clinical significant relevance according to the investigator
• Pregnant women or willing to become pregnant or lactating women
• Women of childbearing age without an efficient contraceptive method according to the investigator
• Patient under a restrictive diet or with a planned weight loss program during the study
• Patient with severe eating disorders (e.g. anorexia nervosa, binge eating disorder and bulimia) according to the investigator
• Patient without stable dietary habits or with specific diet (vegetarian, vegan, gluten-free…) according to the investigator
• Patient who smokes more than 5 cigarettes per day
• Patient regularly consuming more than 20 g/day of alcohol. Consumption of more than 3 alcoholic beverages per day is recognized as excessive. An alcoholic beverage is: 30 mL of spirituous, 120 mL of wine or 330 mL of beer
• Patient regularly consuming recreational drugs
• Adhesive plaster skin allergy
• Claustrophobic patient
• Patient willing to take the plane during the CGMS periods