Evaluation of 2 Diets With Different Starch Digestibility Profiles on Daily Glycemic Profile, in T2D Patients
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): Balanced diet high in Slowly Digestible Starch; Balanced diet low in Slowly Digestible Starch
Intervention type(s): Other; Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each subject will receive two independant weeks of diet intervention, in a crossover design
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Slowly Digestible Starch; SDS; Type 2 diabetes; T2D; Glycemic response; Continuous Glucose Monitoring System; CGMS