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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
9
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.
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.
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Pierre-Bénite, France
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.
Time frame: minimum 2h to maximum 6h postprandial periods and average value of minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: Minimum glycaemia
Minimum glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: maximum glycaemia
maximum glycaemia
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: MODDs
Mean Of Daily Differences (MODDs) from CGMS glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
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Glycemic profile parameters: MIME
Mean Indices of Meal Excursions (MIME) from CGMS glycaemia
Time frame: 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 %
Time frame: 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
Time frame: 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
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: hyperglycemia durations
hyperglycemia durations
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: hypoglycemia durations
hypoglycemia durations
Time frame: 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
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: incremental AUC
incremental AUC calculated on relevant time interval
Time frame: 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
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: kinetics
Daylong glycaemia kinetics
Time frame: 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
Time frame: maximum of 6 days of LogBook record
Dietary intake evaluation
Dietary record analysis, in g of macronutrient intake
Time frame: After 1 week intervention diet
Dietary record evaluation
Dietary record analysis, in % of total energy intake
Time frame: After 1 week intervention diet
Charaterisation of acceptability to H-SDS diet in free living conditions
Feedback questionnaire
Time frame: After 1 week intervention diet