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| Name | Class |
|---|---|
| Centre de Recherche en Nutrition Humaine Rhone-Alpe | OTHER |
| Biofortis Mérieux NutriSciences | OTHER |
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The study is a randomized cross-over pilot study. The research hypothesis is that the diet high in SDS content (H-SDS) will lower the daylong glycemic response and improve the glycemic control in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS).
The study is a randomized cross-over pilot study. The research hypothesis is that the diet high in SDS content (H-SDS) will lower the daylong glycemic response and improve the glycemic control in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS).
8 patients with type 2 diabetic patients will be recruited.
Subjets will have 5 visits:
The selection visit (V1) is required to check whether the patients fulfill inclusion and exclusion criteria for the study.
The visit V2 will include randomization, medical check-up and a dietary interview (LogBook supply with explanations for filling and dietary advice cards for the 1st week of diet). The nurse will insert the CGMS and the patient will receive detailed instructions on wearing the sensor and recorder. The patient will leave the research center with a glucometer, the starchy foods and cereal products adapted for its first week of diet and the associated cooking instruction sheets and menus given by the dietician.
During each day of the first experimental diet period, the patient will take at least four blood glucometer readings per day, and will consume the food products according to a menu plan and the cooking instruction sheets given by the dietician, and fill a dietary record.
After 6 days +/- 1 day, the patient will return to the center (Visit V3) to remove the CGMS, bring back the glucometer and the follow-up LogBook. A Medical check-up will also be performed. Compliance will be assessed using the dietary record of the follow-up LogBook and the return of the uneaten products (weighting). A feedback questionnaire will be completed by each patient to have a global assessment of the diet and to evaluate the feasibility of this type of diet over longer periods.
The wash-out period will then last 2 weeks +/- 3 days. Then a new sequence will start. The visit V4 will be similar to visit V2 with: installation of the CGMS, provision of the LogBook and diet specific information for the second period. The glucometer and starchy foods and cereal products will be supplied to the patients.
During each day of this second diet period, patients will be required to consume starchy foods and cereal products according to a menu plan and cooking instructions provided by the dietician, and fill a dietary record. The patient will realize 4 capillary blood glucose control and will fill the information required in the LogBook.
Finally, Visit V5 will be the last visit. It will include, like for visit V3: removal of CGMS, return of glucometer and follow-up LogBook and a medical check-up . Compliance will be assessed using the dietary record of the follow-up LogBook and the return of the uneaten products (weighting). A feedback questionnaire will be completed by patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet A | Active Comparator | Balanced diet high in Slowly Digestible Starch |
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| Diet B | Placebo Comparator | Balanced diet low in Slowly Digestible Starch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balanced diet high in Slowly Digestible Starch | Other | The carbohydrate present in the diet high in Slowly Digestible Starch were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during one week. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean postprandial incremental Area Under the Curve (iAUC), measured by CGMS | 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. | minimum 2h to maximum 6h postprandial periods and average value of minimum 3 days to a maximum of 6 days of CGMS record |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic profile parameters: Minimum glycaemia | Minimum glycaemia | minimum 3 days to a maximum of 6 days of CGMS record |
| Glycemic profile parameters: maximum glycaemia | maximum glycaemia |
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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:
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:
Biological criteria:
Therapeutic and medical criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel DISSE, MD, PhD | Centre de Recherche en Nutrition Humaine Rhone-Alpe | Principal Investigator |
| Martine LAVILLE, MD, PhD | Centre de Recherche en Nutrition Humaine Rhone-Alpe | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherche en Nutrition Humaine Rhone-Alpe | Pierre-Bénite | 69310 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32988721 | Derived | Breyton AE, Goux A, Lambert-Porcheron S, Meynier A, Sothier M, VanDenBerghe L, Brack O, Disse E, Laville M, Vinoy S, Nazare JA. Starch digestibility modulation significantly improves glycemic variability in type 2 diabetic subjects: A pilot study. Nutr Metab Cardiovasc Dis. 2021 Jan 4;31(1):237-246. doi: 10.1016/j.numecd.2020.08.010. Epub 2020 Aug 25. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Each subject will receive two independant weeks of diet intervention, in a crossover design
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Each diet will be labelled "Diet A" or "Diet B"
| Balanced diet low in Slowly Digestible Starch | Other | The carbohydrate present in the diet low in Slowly Digestible Starch were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during one week. |
|
| minimum 3 days to a maximum of 6 days of CGMS record |
| Glycemic profile parameters: Standard Deviation (SD) from CGMS glycaemia | Standard Deviation (SD) from CGMS glycaemia | minimum 3 days to a maximum of 6 days of CGMS record |
| Glycemic profile parameters: Coefficient of Variation (CV) from CGMS glycaemia | Coefficient of Variation (CV) from CGMS glycaemia | minimum 3 days to a maximum of 6 days of CGMS record |
| Glycemic profile parameters: 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: MODDs | Mean Of Daily Differences (MODDs) from CGMS glycaemia | minimum 3 days to a maximum of 6 days of CGMS record |
| Glycemic profile parameters: 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: Time in Range | Mean time spent in the appropriate glycemic range in % | minimum 3 days to a maximum of 6 days of CGMS record |
| Glycemic profile parameters: ADRR | Average of Daily Risk Ratio (ADRR) from CGMS glycaemia | minimum 3 days to a maximum of 6 days of CGMS record |
| Glycemic profile parameters: 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: hyperglycemia durations | hyperglycemia durations | minimum 3 days to a maximum of 6 days of CGMS record |
| Glycemic profile parameters: hypoglycemia durations | hypoglycemia durations | minimum 3 days to a maximum of 6 days of CGMS record |
| Glycemic profile parameters: mean glycemic value | mean glycemic value on relevant time interval | minimum 3 days to a maximum of 6 days of CGMS record |
| Glycemic profile parameters: incremental AUC | incremental AUC calculated on relevant time interval | minimum 3 days to a maximum of 6 days of CGMS record |
| Glycemic profile parameters: total AUC | total AUC calculated on relevant time interval, calculated using the trapezoid rule and including all area below the curve | minimum 3 days to a maximum of 6 days of CGMS record |
| Glycemic profile parameters: kinetics | Daylong glycaemia kinetics | minimum 3 days to a maximum of 6 days of CGMS record |
| Compliance parameters: mean SDS ingestion | mean SDS ingestion by type of meal and per day | maximum of 6 days of LogBook record |
| Dietary intake evaluation | Dietary record analysis, in g of macronutrient intake | After 1 week intervention diet |
| Dietary record evaluation | Dietary record analysis, in % of total energy intake | After 1 week intervention diet |
| Charaterisation of acceptability to H-SDS diet in free living conditions | Feedback questionnaire | After 1 week intervention diet |
| D004700 | Endocrine System Diseases |