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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Other: Balanced diet high in Slowly Digestible Starch
* Other: Balanced diet low in Slowly Digestible Starch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each participant will be allocated to an intervention arm in a parallel design for 3 months of intervention
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High in SDS<br>Balanced diet high in Slowly Digestible Starch | Other: Balanced diet high in Slowly Digestible Starch<br>* The carbohydrates present in high Slowly Digestible Starch diet were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during three months.<br>* Other names: H-SDS;|
| Placebo Comparator: Low in SDS<br>Balanced diet low in Slowly Digestible Starch | Other: Balanced diet low in Slowly Digestible Starch<br>* The carbohydrates present in low-Slowly Digestible Starch diet were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during three months.<br>* Other names: L-SDS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAGE comparison following 3 months of intake of a diet either high or low in SDS | Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia | Minimum 3 days to a maximum of 6 days of CGMS record | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemia iAUC characterisation of a standard challenge test (FlexMeal) during the first metabolic day | Glycemia iAUC | 5 hours post standard challenge test during visit 3 | 
| Insulin iAUC characterisation of a standard challenge test (FlexMeal) during the first metabolic day | Insulin iAUC | 5 hours post standard challenge test during visit 3 | 
| GLP1 iAUC characterisation of a standard challenge test (FlexMeal) during the first metabolic day | GLP1 iAUC | 5 hours post standard challenge test during visit 3 | 
| Inflammatory status comparison during the first metabolic day : CRPus concentration | CRPus | At a basal state during visit 3 | 
| Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the first metabolic day : TNFa iAUC | TNFa iAUC | 5 hours post standard challenge test during visit 3 | 
| Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the first metabolic day : IL6 iAUC | IL6 iAUC | 5 hours post standard challenge test during visit 3 | 
| Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the first metabolic day : IL1Ra iAUC | IL1Ra iAUC | 5 hours post standard challenge test during visit 3 | 
| Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the first metabolic day : IL18 iAUC | IL18 iAUC | 5 hours post standard challenge test during visit 3 | 
| Glycemic impacts comparison following the intake of a diet either high or low in SDS during the time course of the study | Glycemia concentration | At a basal state during visit 3, visit 6 and visit 10 | 
| Insulinemic impacts comparison following the intake of a diet either high or low in SDS during the time course of the study | Insulin concentration | At a basal state during visit 3, visit 6 and visit 10 | 
| Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : CRPus concentration | CRPus concentration | At a basal state during visit 3, visit 6 and visit 10 | 
| Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : TNFa concentration | TNFa concentration | At a basal state during visit 3, visit 6 and visit 10 | 
| Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : IL6 concentration | IL6 concentration | At a basal state during visit 3, visit 6 and visit 10 | 
| Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : IL1Ra concentration | IL1Ra concentration | At a basal state during visit V3, V6 and V10 | 
| Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : IL18 concentration | IL18 concentration | At a basal state during visit 3, visit 6 and visit 10 | 
| Oxidative Stress comparison following the intake of a diet either high or low in SDS during the time course of the study : MDA concentration | Malonaldehyde : MDA concentration | At a basal state during visit 3, visit 6 and visit 10 | 
| Oxidative Stress comparison following the intake of a diet either high or low in SDS during the time course of the study : Urinary isoprostanes concentration | Urinary isoprostanes concentration | At a basal state during visit 3, visit 6 and visit 10 | 
| Cardiovascular risk markers comparison following the intake of a diet either high or low in SDS during the time course of the study : MCP1 concentration | MCP1 concentration | At a basal state during visit 3, visit 6 and visit 10 | 
| Cardiovascular risk markers comparison following the intake of a diet either high or low in SDS during the time course of the study : sICAM concentration | sICAM concentration | At a basal state during visit 3, visit 6 and visit 10 | 
| Cardiovascular risk markers comparison following the intake of a diet either high or low in SDS during the time course of the study : sVCAM concentration | sVCAM concentration | At a basal state during visit 3, visit 6 and visit 10 | 
| Glycemic impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day | Glycemia iAUC | 5 hours post standard challenge test during visit 10 | 
| Insulinemic impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day | Insulin iAUC | 5 hours post standard challenge test during visit 10 | 
| GLP1 iAUC characterisation of a standard challenge test (FlexMeal) during the second metabolic day | GLP1 iAUC | 5 hours post standard challenge test during visit 10 | 
| Inflammatory impacts comparison following 3 months of intake of a diet either high or low in SDS : CRPus concentration | CRPus concentration | At a basal state during visit 10 | 
| Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : TNFa iAUC | TNFa iAUC | 5 hours post standard challenge test during visit 10 | 
| Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL6 iAUC | IL6 iAUC | 5 hours post standard challenge test during visit 10 | 
| Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL1Ra iAUC | IL1Ra iAUC | 5 hours post standard challenge test during visit 10 | 
| Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL18 iAUC | IL18 iAUC | 5 hours post standard challenge test during visit 10 | 
| Cardiovascular risk markers characterisation following the intake of a diet either high or low in SDS : MCP1 concentration | MCP1 concentration | After 3 months consumption of the diet | 
| Cardiovascular risk markers characterisation following the intake of a diet either high or low in SDS : sICAM concentration | sICAM concentration | After 3 months consumption of the diet | 
| Cardiovascular risk markers characterisation following the intake of a diet either high or low in SDS : sVCAM concentration | sVCAM concentration | After 3 months consumption of the diet | 
| Oxydative stress characterisation following the intake of a diet either high or low in SDS : MDA concentration | Malonaldehyde : MDA concentration | After 3 months consumption of the diet | 
| Oxydative stress characterisation following the intake of a diet either high or low in SDS : Urinary isoprostanes concentration | Urinary isoprostanes concentration | After 3 months consumption of the diet | 
| Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : MAGE | Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia | minimum 3 days to a maximum of 6 days of CGMS record | 
| Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : MAGE | Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia | after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days | 
| Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : TIR | Time In Range (TIR) from CGMS glycaemia | minimum 3 days to a maximum of 6 days of CGMS record | 
| Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : TIR | Time In Range (TIR) from CGMS glycaemia | after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days | 
| Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : CV | Coefficient of Variation (CV) from CGMS glycaemia | minimum 3 days to a maximum of 6 days of CGMS record | 
| Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : CV | Coefficient of Variation (CV) from CGMS glycaemia | after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days | 
| Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : SD | Standard Deviation (SD) from CGMS glycaemia | minimum 3 days to a maximum of 6 days of CGMS record | 
| Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : SD | Standard Deviation (SD) from CGMS glycaemia | after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days | 
| Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : MIME | Mean Indices of Meal Excursions (MIME) from CGMS glycaemia | minimum 3 days to a maximum of 6 days of CGMS record | 
| Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : MIME | Mean Indices of Meal Excursions (MIME) from CGMS glycaemia | after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days | 
| Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : MODD | Mean Of Daily Differences (MODD) from CGMS glycaemia | minimum 3 days to a maximum of 6 days of CGMS record | 
| Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : MODD | Mean Of Daily Differences (MODD) from CGMS glycaemia | after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days | 
| Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : CONGA | Continuous Overall Net Glycemic Action (CONGA) from CGMS glycaemia | minimum 3 days to a maximum of 6 days of CGMS record | 
| Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : CONGA | Continuous Overall Net Glycemic Action (CONGA) from CGMS glycaemia | after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days | 
| Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : ADRR | Average Daily Risk Range (ADRR) from CGMS glycaemia | minimum 3 days to a maximum of 6 days of CGMS record | 
| Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : ADRR | Average Daily Risk Range (ADRR) from CGMS glycaemia | after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days | 
| Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : LGBI | Low Blood Glucose Index (LGBI) from CGMS glycaemia | minimum 3 days to a maximum of 6 days of CGMS record | 
| Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : LGBI | Low Blood Glucose Index (LGBI) from CGMS glycaemia | after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days | 
| Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : HGBI | High Blood Glucose Index (HGBI) from CGMS glycaemia | minimum 3 days to a maximum of 6 days of CGMS record | 
| Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : HGBI | High Blood Glucose Index (HGBI) from CGMS glycaemia | after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days | 
| Mean daylong incremental Area Under the Curve (iAUC), measured by CGMS, following the intake of a diet either high or low in SDS during the time course of the study | The iAUC will be calculated using the trapezoid rule. The iAUC includes all area below the curve and above the fasting concentration, with any area beneath fasting being ignored. | from 0 min to 360 min postprandial during the CGMS record periods (from visit 3 to visit 4, from visit 6 to visit 7 and from visit 9 to visit 10) | 
| Mean daylong total Area Under the Curve (tAUC), measured by CGMS, following the intake of a diet either high or low in SDS during the time course of the study | The tAUC will be calculated using the trapezoid rule. | from 0 min to 360 min postprandial during the CGMS record periods (from visit 3 to visit 4, from visit 6 to visit 7 and from visit 9 to visit 10) | 
| Compare diabetes follow-up markers during the first metabolic day : HbA1c | Hba1c concentration | At the basal state during visit 3 | 
| Compare diabetes follow-up markers following the intake of a diet either high or low in SDS during the time course of the study : HbA1c concentration | Hba1c | At a basal state, during visit 3, visit 6 and visit 10 | 
| Compare diabetes follow-up markers following the 3 months consumption of a diet either high or low in SDS : HbA1c concentration | Hba1c | After 3 months consumption of the diet, at the basal state | 
| Compare Diabetes follow-up markers during the first metabolic day : Fructosamine concentration | Fructosamine | At the basal state during visit 3 | 
| Compare Diabetes follow-up markers following the intake of a diet either high or low in SDS during the time course of the study : fructosamine concentration | Fructosamine | At a basal state, during visit 3, visit 6 and visit 10 | 
| Compare Diabetes follow-up markers following the 3 months consumption of a diet either high or low in SDS : Fructosamine concentration | Fructosamine | After 3 months consumption of the diet, at the basal state | 
| Compare Diabetes follow-up markers during the first metabolic day : Glycated Albumin concentration | Glycated albumin | At the basal state during visit 3 | 
| Compare Diabetes follow-up markers following the intake of a diet either high or low in SDS during the time course of the study : glycated albumin concentration | Glycated albumin | At a basal state, during visit 3, visit 6 and visit 10 | 
| Compare Diabetes follow-up markers following the 3 months consumption of a diet either high or low in SDS : Glycated Albumin concentration | Glycated albumin | After 3 months consumption of the diet, at the basal state | 
| Arterial Endothelial Function characterisation following the intake of a diet either high or low in SDS during the time course of the study : RHI | Reactive Hyperemia (RHI) | At a basal state during visit 4, visit 7 and visit 9 | 
| Arterial Endothelial Function characterisation following the intake of a diet either high or low in SDS during the time course of the study : AI | Augmentation Index (AI) | At a basal state during visit 4, visit 7 and visit 9 | 
| Arterial Endothelial Function characterisation following the intake of a diet either high or low in SDS during the time course of the study : HRV | Heart Rate Variability (HRV) | At a basal state during visit 4, visit 7 and visit 9 | 
| Anthropometry parameters characterisation during the first metabolic day : height | Height | At baseline during visit 3 | 
| Anthropometry parameters characterisation during the first metabolic day : body weight | body weight | At baseline during visit 3 | 
| Anthropometry parameters characterisation during the first metabolic day : waist circumference | waist circumference | At baseline during visit 3 | 
| Anthropometry parameters characterisation during the first metabolic day : hip circumference | hip circumference | At baseline during visit 3 | 
| Anthropometry parameters characterisation following the intake of a diet either high or low in SDS during the time course of the study : height | Height | At baseline during visit 3, visit 6 and visit 10 | 
| Anthropometry parameters characterisation following the intake of a diet either high or low in SDS during the time course of the study : body weight | body weight | At baseline during visit 3, visit 6 and visit 10 | 
| Anthropometry parameters characterisation following the intake of a diet either high or low in SDS during the time course of the study : waist circumference | waist circumference | At baseline during visit 3, visit 6 and visit 10 | 
| Anthropometry parameters characterisation following the intake of a diet either high or low in SDS during the time course of the study : hip circumference | hip circumference | At baseline during visit 3, visit 6 and visit 10 | 
| Anthropometry parameters characterisation following the 3 months consumption of a diet either high or low in SDS : height | Height | At baseline during visit 10 | 
| Anthropometry parameters characterisation following the 3 months consumption of a diet either high or low in SDS : body weight | body weight | At baseline during visit 10 | 
| Anthropometry parameters characterisation following the 3 months consumption of a diet either high or low in SDS : waist circumference | waist circumference | At baseline during visit 10 | 
| Anthropometry parameters characterisation following the 3 months consumption of a diet either high or low in SDS : hip circumference | hip circumference | At baseline during visit 10 | 
| Body composition parameters characterisation during the first metabolic day: total body water | Total body water measured by bioimpedancemetry | At baseline during visit 3 | 
| Body composition parameters characterisation during the first metabolic day: body fat | Body fat measured by bioimpedancemetry | At baseline during visit 3 | 
| Body composition parameters characterisation during the first metabolic day: lean mass. | Lean mass measured by bioimpedancemetry | At baseline during visit 3 | 
| Body composition parameters characterisation following the 3 months consumption of a diet either high or low in SDS : total body water | Total body water measured by bioimpedancemetry | At baseline during visit 10 | 
| Body composition parameters characterisation following the 3 months consumption of a diet either high or low in SDS : body fat | Body fat measured by bioimpedancemetry | At baseline during visit 10 | 
| Body composition parameters characterisation following the 3 months consumption of a diet either high or low in SDS : lean mass | Lean mass measured by bioimpedancemetry | At baseline during visit 10 | 
| Resting energy metabolism profile during the first metabolic day: Resting Metabolism Rate | Resting Metabolism Rate (RMR) | At baseline during visit 3 | 
| Resting energy metabolism profile following the 3 months consumption of a diet either high or low in SDS : Resting Metabolism Rate | Resting Metabolism Rate (RMR) | At baseline during visit 10 | 
| Diabetic glycemic variability characterisation following the 3 months consumption of a diet either high or low in SDS | Percent of subjects reaching the target for HbA1C, TIR and CV | after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days | 
| Level of physical activity characterisation following the intake of a diet either high or low in SDS during the time course of the study : IPAQ | International Physical Activity Questionnaire (IPAQ) | After each CGMS record periods, ie : at visit 4, visit 7 and visit 10 | 
| Characterisation of acceptability to H-SDS diet in free living conditions | Feedback questionnaire | After 3 months consumption of the diet, at visit 10 | 
| Characterisation of the percent of compliance to H-SDS diet in free living conditions | Table of compliance in the volunteer's notebook. Subjects will have to fulfill it after each meal during the study period | After 3 months consumption of the diet | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Slowly Digestible Starch, SDS, Type 2 diabetes, T2D, Glycemic response, Continuous Glucose Monitoring System, CGMS, Diet, MAGE, Mean Amplitude of Glucose Excursion