Evaluation of 2 Diets With Different Starch Digestibility Profiles on Daily Glycemic Profile, in T2D 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 Read More

Inclusion Criteria:

• Patient able to understand the study information and providing written consents 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 6,5% and 8,5%
  • Bi-therapy associating metformin and sitagliptin at stable dose for at least 1 month
• T2D volunteer without insulin therapy or GLP-1 analogues
• Patient with BMI ranging between 22 and 37 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 two weeks
• Patient not suffering from intolerance or allergy
• Patient regularly consuming products proposed in the study
• Patient regularly consuming 3 main meals per day
• Sedentary behavior or stable regular 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 assurance

Exclusion Criteria:

• General 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

• Biological criteria:

  • 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
  • Other biological abnormality with clinical significant relevance according to the investigator

• Therapeutic and medical criteria:

  • Patient with type 1 diabetes
  • T2D treatment other than metformin and sitagliptin
  • Patient with past bariatric surgery
  • Patient with medical history of endocrine diseases who may interfere with glucose metabolism according to the investigator (such as thyroid dysfunction, acromegaly, hypercorticism…)
  • 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 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 willing to lose weight
  • Patient with eating disorders (e.g. anorexia nervosa and bulimia) according to the investigator
  • Patient without stable dietary habits or with specific diet (vegetarian, vegan,…) according to the investigator
  • Patient who smokes
  • 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
  • Patient consuming in the two previous months regularly corticoids, anorectics, adrenergic drugs, beta-blocking drugs, antiplatelet agent (like aspirin) or other drugs or supplement that should impact glucose metabolism (other than metformin or DPP4 inhibitor) in the investigator's opinion
  • Adhesive plaster skin allergy