Cardio-metabolic and Inflammatory Impact of Starch Digestibility in Type 2 Diabetic Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Type2 Diabetes
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Each participant will be allocated to an intervention arm in a parallel design for 3 months of interventionMasking: Double (Participant, Outcomes Assessor)Masking Description: Each diet will be labelled "Diet A" or "Diet B"Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
This is a monocentric, randomized, single-blind and controlled study with a parallel design (2 arms). The research hypothesis is that the diet high in Slow Digestible Starch (SDS) content (H-SDS) will lower the daylong glycemic response and improve the glycemic control just as metabolic, inflammator...
This is a monocentric, randomized, single-blind and controlled study with a parallel design (2 arms). The research hypothesis is that the diet high in Slow Digestible Starch (SDS) content (H-SDS) will lower the daylong glycemic response and improve the glycemic control just as metabolic, inflammatory, cardiovascular and oxidative stress parameters in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS). The hypothesis is that these differences in glycemic response and in metabolic, inflammatory, cardiovascular and oxidative stress parameters response can be observed after 3 months of diet. 80 patients with type 2 diabetes will be recruited. Subjects will have 11 visits: V0 = selection visit: check whether the patients fulfill inclusion and exclusion criteria for the study. Visit V1 = CGMS insertion on usual lifestyle without any changes in his/her diet. This is the Run-in period. Visit V2 (6 days +/- 1 day) = CGMS removal and randomization according to sex, HbA1c and MAGE. Visit V3 = first metabolic day: medical check-up, dietary interview, indirect calorimetry, impedancemetry measurements and FlexMeal challenge test with 5h follow up (blood samples). CGMS insertion with detailed dietetic instructions according to their allocated group (adapted food provisions). Visit V4 (6 days +/- 1 day) = CGMS removal. Arterial Endothelial Function (AEF) measurement. Adapted food provisions. Visit V5 = Adapted food provisions. Visit V6 = medical check-up, dietary interview, CGMS insertion and baseline blood measurements. Adapted food provisions. Visit V7 (6 days +/- 1 day) = CGMS removal. Arterial Endothelial Function (AEF) measurement. Adapted food provisions. Visit V8 = Adapted food provisions. Visit V9 = CGMS insertion. Arterial Endothelial Function (AEF) measurement. Adapted food provisions. Visit V10 (6 days +/- 1 day) = second metabolic day: medical check-up, dietary interview, indirect calorimetry, impedancemetry measurements and FlexMeal challenge test with 5h follow up (blood samples). CGMS removal. Feedback questionnaire.
Tracking Information
- NCT #
- NCT03847701
- Collaborators
- Centre de Recherche en Nutrition Humaine Rhone-Alpe
- Biofortis Mérieux NutriSciences
- Investigators
- Principal Investigator: Emmanuel DISSE, MD, PhD Centre de Recherche en Nutrition Humaine Rhône-Alpes Study Chair: Martine LAVILLE, MD, PhD Centre de Recherche en Nutrition Humaine Rhône-Alpes
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