<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03289494</url>
  </required_header>
  <id_info>
    <org_study_id>KBE052</org_study_id>
    <nct_id>NCT03289494</nct_id>
  </id_info>
  <brief_title>Evaluation of 2 Diets With Different Starch Digestibility Profiles on Daily Glycemic Profile, in T2D Patients</brief_title>
  <official_title>A Pilot Randomized Controlled Trial Evaluating the Effect of Two Diets With Different Starch Digestibility Profiles on Daily Glycemic Profile Measured by Continuous Glucose Monitoring System (CGMS), in Type 2 Diabetic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mondelēz International, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre de Recherche en Nutrition Humaine Rhone-Alpe</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Biofortis Mérieux NutriSciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mondelēz International, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a randomized cross-over pilot study. The research hypothesis is that the diet&#xD;
      high in SDS content (H-SDS) will lower the daylong glycemic response and improve the glycemic&#xD;
      control in patients with type 2 diabetes (T2D) compared to the diet low in SDS content&#xD;
      (L-SDS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a randomized cross-over pilot study. The research hypothesis is that the diet&#xD;
      high in SDS content (H-SDS) will lower the daylong glycemic response and improve the glycemic&#xD;
      control in patients with type 2 diabetes (T2D) compared to the diet low in SDS content&#xD;
      (L-SDS).&#xD;
&#xD;
      8 patients with type 2 diabetic patients will be recruited.&#xD;
&#xD;
      Subjets will have 5 visits:&#xD;
&#xD;
      The selection visit (V1) is required to check whether the patients fulfill inclusion and&#xD;
      exclusion criteria for the study.&#xD;
&#xD;
      The visit V2 will include randomization, medical check-up and a dietary interview (LogBook&#xD;
      supply with explanations for filling and dietary advice cards for the 1st week of diet). The&#xD;
      nurse will insert the CGMS and the patient will receive detailed instructions on wearing the&#xD;
      sensor and recorder. The patient will leave the research center with a glucometer, the&#xD;
      starchy foods and cereal products adapted for its first week of diet and the associated&#xD;
      cooking instruction sheets and menus given by the dietician.&#xD;
&#xD;
      During each day of the first experimental diet period, the patient will take at least four&#xD;
      blood glucometer readings per day, and will consume the food products according to a menu&#xD;
      plan and the cooking instruction sheets given by the dietician, and fill a dietary record.&#xD;
&#xD;
      After 6 days +/- 1 day, the patient will return to the center (Visit V3) to remove the CGMS,&#xD;
      bring back the glucometer and the follow-up LogBook. A Medical check-up will also be&#xD;
      performed. Compliance will be assessed using the dietary record of the follow-up LogBook and&#xD;
      the return of the uneaten products (weighting). A feedback questionnaire will be completed by&#xD;
      each patient to have a global assessment of the diet and to evaluate the feasibility of this&#xD;
      type of diet over longer periods.&#xD;
&#xD;
      The wash-out period will then last 2 weeks +/- 3 days. Then a new sequence will start. The&#xD;
      visit V4 will be similar to visit V2 with: installation of the CGMS, provision of the LogBook&#xD;
      and diet specific information for the second period. The glucometer and starchy foods and&#xD;
      cereal products will be supplied to the patients.&#xD;
&#xD;
      During each day of this second diet period, patients will be required to consume starchy&#xD;
      foods and cereal products according to a menu plan and cooking instructions provided by the&#xD;
      dietician, and fill a dietary record. The patient will realize 4 capillary blood glucose&#xD;
      control and will fill the information required in the LogBook.&#xD;
&#xD;
      Finally, Visit V5 will be the last visit. It will include, like for visit V3: removal of&#xD;
      CGMS, return of glucometer and follow-up LogBook and a medical check-up . Compliance will be&#xD;
      assessed using the dietary record of the follow-up LogBook and the return of the uneaten&#xD;
      products (weighting). A feedback questionnaire will be completed by patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2017</start_date>
  <completion_date type="Actual">July 24, 2018</completion_date>
  <primary_completion_date type="Actual">July 24, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Each subject will receive two independant weeks of diet intervention, in a crossover design</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Each diet will be labelled &quot;Diet A&quot; or &quot;Diet B&quot;</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mean postprandial incremental Area Under the Curve (iAUC), measured by CGMS</measure>
    <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</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycemic profile parameters: Minimum glycaemia</measure>
    <time_frame>minimum 3 days to a maximum of 6 days of CGMS record</time_frame>
    <description>Minimum glycaemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic profile parameters: maximum glycaemia</measure>
    <time_frame>minimum 3 days to a maximum of 6 days of CGMS record</time_frame>
    <description>maximum glycaemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic profile parameters: Standard Deviation (SD) from CGMS glycaemia</measure>
    <time_frame>minimum 3 days to a maximum of 6 days of CGMS record</time_frame>
    <description>Standard Deviation (SD) from CGMS glycaemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic profile parameters: Coefficient of Variation (CV) from CGMS glycaemia</measure>
    <time_frame>minimum 3 days to a maximum of 6 days of CGMS record</time_frame>
    <description>Coefficient of Variation (CV) from CGMS glycaemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic profile parameters: MAGE</measure>
    <time_frame>minimum 3 days to a maximum of 6 days of CGMS record</time_frame>
    <description>Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic profile parameters: MODDs</measure>
    <time_frame>minimum 3 days to a maximum of 6 days of CGMS record</time_frame>
    <description>Mean Of Daily Differences (MODDs) from CGMS glycaemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic profile parameters: MIME</measure>
    <time_frame>minimum 3 days to a maximum of 6 days of CGMS record</time_frame>
    <description>Mean Indices of Meal Excursions (MIME) from CGMS glycaemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic profile parameters: Time in Range</measure>
    <time_frame>minimum 3 days to a maximum of 6 days of CGMS record</time_frame>
    <description>Mean time spent in the appropriate glycemic range in %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic profile parameters: ADRR</measure>
    <time_frame>minimum 3 days to a maximum of 6 days of CGMS record</time_frame>
    <description>Average of Daily Risk Ratio (ADRR) from CGMS glycaemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic profile parameters: CONGA</measure>
    <time_frame>minimum 3 days to a maximum of 6 days of CGMS record</time_frame>
    <description>Continuous Overall Net Glycemic Action (CONGA) from CGMS glycaemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic profile parameters: hyperglycemia durations</measure>
    <time_frame>minimum 3 days to a maximum of 6 days of CGMS record</time_frame>
    <description>hyperglycemia durations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic profile parameters: hypoglycemia durations</measure>
    <time_frame>minimum 3 days to a maximum of 6 days of CGMS record</time_frame>
    <description>hypoglycemia durations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic profile parameters: mean glycemic value</measure>
    <time_frame>minimum 3 days to a maximum of 6 days of CGMS record</time_frame>
    <description>mean glycemic value on relevant time interval</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic profile parameters: incremental AUC</measure>
    <time_frame>minimum 3 days to a maximum of 6 days of CGMS record</time_frame>
    <description>incremental AUC calculated on relevant time interval</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic profile parameters: total AUC</measure>
    <time_frame>minimum 3 days to a maximum of 6 days of CGMS record</time_frame>
    <description>total AUC calculated on relevant time interval, calculated using the trapezoid rule and including all area below the curve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic profile parameters: kinetics</measure>
    <time_frame>minimum 3 days to a maximum of 6 days of CGMS record</time_frame>
    <description>Daylong glycaemia kinetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance parameters: mean SDS ingestion</measure>
    <time_frame>maximum of 6 days of LogBook record</time_frame>
    <description>mean SDS ingestion by type of meal and per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intake evaluation</measure>
    <time_frame>After 1 week intervention diet</time_frame>
    <description>Dietary record analysis, in g of macronutrient intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary record evaluation</measure>
    <time_frame>After 1 week intervention diet</time_frame>
    <description>Dietary record analysis, in % of total energy intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Charaterisation of acceptability to H-SDS diet in free living conditions</measure>
    <time_frame>After 1 week intervention diet</time_frame>
    <description>Feedback questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Diet A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Balanced diet high in Slowly Digestible Starch</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diet B</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Balanced diet low in Slowly Digestible Starch</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Balanced diet high in Slowly Digestible Starch</intervention_name>
    <description>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.</description>
    <arm_group_label>Diet A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Balanced diet low in Slowly Digestible Starch</intervention_name>
    <description>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.</description>
    <arm_group_label>Diet B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient able to understand the study information and providing written consents for&#xD;
             his/her participation to the study&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Patient undergoing medical examination during the selection visit&#xD;
&#xD;
          -  Patient aged between 18 and 75 years old (bounds included)&#xD;
&#xD;
          -  T2D volunteer with:&#xD;
&#xD;
               -  HbA1c between 6,5% and 8,5%&#xD;
&#xD;
               -  Bi-therapy associating metformin and sitagliptin at stable dose for at least 1&#xD;
                  month&#xD;
&#xD;
          -  T2D volunteer without insulin therapy or GLP-1 analogues&#xD;
&#xD;
          -  Patient with BMI ranging between 22 and 37 kg/m2 (bounds included)&#xD;
&#xD;
          -  Patient with stable body weight over the past three months (+/- 5 % of body weight)&#xD;
&#xD;
          -  Patient accepting to change its diet for two weeks&#xD;
&#xD;
          -  Patient not suffering from intolerance or allergy&#xD;
&#xD;
          -  Patient regularly consuming products proposed in the study&#xD;
&#xD;
          -  Patient regularly consuming 3 main meals per day&#xD;
&#xD;
          -  Sedentary behavior or stable regular physical activity during the study&#xD;
&#xD;
          -  Patient not presenting any disease during the medical examination / interview which&#xD;
             could interfere with the results of the study according to the investigator&#xD;
&#xD;
          -  Patient covered by health assurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  General criteria:&#xD;
&#xD;
               -  Patient under legal protection measure&#xD;
&#xD;
               -  Patient deprived of liberty by a court or an administrative decision&#xD;
&#xD;
               -  Patient currently participating in another study or being in the exclusion period&#xD;
                  of another study&#xD;
&#xD;
               -  Volunteer that exceed the financial compensation allowed per year for&#xD;
                  participating in research programs&#xD;
&#xD;
          -  Biological criteria:&#xD;
&#xD;
               -  Gamma-GT &gt; 2.5 times above the norm (&gt;160 UI/L)&#xD;
&#xD;
               -  ASAT &gt; 2.5 times above the norm (&gt;85 UI/L)&#xD;
&#xD;
               -  ALAT &gt; 2.5 times above the norm (&gt;137.5 UI/L)&#xD;
&#xD;
               -  Triglycerides &gt; 4 g/L&#xD;
&#xD;
               -  LDL-cholesterol &gt; 1.90 g/L&#xD;
&#xD;
               -  CRP &gt; 15 mg/L&#xD;
&#xD;
               -  Hemoglobin &lt; 120 mg/dL&#xD;
&#xD;
               -  Other biological abnormality with clinical significant relevance according to the&#xD;
                  investigator&#xD;
&#xD;
          -  Therapeutic and medical criteria:&#xD;
&#xD;
               -  Patient with type 1 diabetes&#xD;
&#xD;
               -  T2D treatment other than metformin and sitagliptin&#xD;
&#xD;
               -  Patient with past bariatric surgery&#xD;
&#xD;
               -  Patient with medical history of endocrine diseases who may interfere with glucose&#xD;
                  metabolism according to the investigator (such as thyroid dysfunction,&#xD;
                  acromegaly, hypercorticism…)&#xD;
&#xD;
               -  Uncontrolled high blood pressure defined by Systolic blood pressure &gt; 150 mmHg or&#xD;
                  Diastolic blood pressure &gt; 100 mmHg&#xD;
&#xD;
               -  Evidence of any other unstable or untreated clinically significant immunological,&#xD;
                  neoplasic, endocrine, haematological, gastrointestinal, hepatic, neurological or&#xD;
                  psychiatric abnormalities or medical disease according to the investigator&#xD;
&#xD;
               -  Pregnant women or willing to become pregnant or lactating women&#xD;
&#xD;
               -  Women of childbearing age without an efficient contraceptive method according to&#xD;
                  the investigator&#xD;
&#xD;
               -  Patient under a restrictive diet or willing to lose weight&#xD;
&#xD;
               -  Patient with eating disorders (e.g. anorexia nervosa and bulimia) according to&#xD;
                  the investigator&#xD;
&#xD;
               -  Patient without stable dietary habits or with specific diet (vegetarian, vegan,…)&#xD;
                  according to the investigator&#xD;
&#xD;
               -  Patient who smokes&#xD;
&#xD;
               -  Patient regularly consuming more than 20 g/day of alcohol. Consumption of more&#xD;
                  than 3 alcoholic beverages per day is recognized as excessive. An alcoholic&#xD;
                  beverage is: 30 mL of spirituous, 120 mL of wine or 330 mL of beer&#xD;
&#xD;
               -  Patient regularly consuming recreational drugs&#xD;
&#xD;
               -  Patient consuming in the two previous months regularly corticoids, anorectics,&#xD;
                  adrenergic drugs, beta-blocking drugs, antiplatelet agent (like aspirin) or other&#xD;
                  drugs or supplement that should impact glucose metabolism (other than metformin&#xD;
                  or DPP4 inhibitor) in the investigator's opinion&#xD;
&#xD;
               -  Adhesive plaster skin allergy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emmanuel DISSE, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre de Recherche en Nutrition Humaine Rhône-Alpes</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martine LAVILLE, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Centre de Recherche en Nutrition Humaine Rhône-Alpes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre de Recherche en Nutrition Humaine Rhone-Alpe</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>May 25, 2020</last_update_submitted>
  <last_update_submitted_qc>May 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Slowly Digestible Starch</keyword>
  <keyword>SDS</keyword>
  <keyword>Type 2 diabetes</keyword>
  <keyword>T2D</keyword>
  <keyword>Glycemic response</keyword>
  <keyword>Continuous Glucose Monitoring System</keyword>
  <keyword>CGMS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03289494
org study id: KBE052
nct id: NCT03289494
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Each subject will receive two independant weeks of diet intervention, in a crossover design
primary purpose: Prevention
masking: Single (Participant)
masking description: Each diet will be labelled "Diet A" or "Diet B"
measure: Mean postprandial incremental Area Under the Curve (iAUC), measured by CGMS
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
description: 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.
measure: Glycemic profile parameters: Minimum glycaemia
time frame: minimum 3 days to a maximum of 6 days of CGMS record
description: Minimum glycaemia
measure: Glycemic profile parameters: maximum glycaemia
time frame: minimum 3 days to a maximum of 6 days of CGMS record
description: maximum glycaemia
measure: Glycemic profile parameters: Standard Deviation (SD) from CGMS glycaemia
time frame: minimum 3 days to a maximum of 6 days of CGMS record
description: Standard Deviation (SD) from CGMS glycaemia
measure: Glycemic profile parameters: Coefficient of Variation (CV) from CGMS glycaemia
time frame: minimum 3 days to a maximum of 6 days of CGMS record
description: Coefficient of Variation (CV) from CGMS glycaemia
measure: Glycemic profile parameters: MAGE
time frame: minimum 3 days to a maximum of 6 days of CGMS record
description: Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia
measure: Glycemic profile parameters: MODDs
time frame: minimum 3 days to a maximum of 6 days of CGMS record
description: Mean Of Daily Differences (MODDs) from CGMS glycaemia
measure: Glycemic profile parameters: MIME
time frame: minimum 3 days to a maximum of 6 days of CGMS record
description: Mean Indices of Meal Excursions (MIME) from CGMS glycaemia
measure: Glycemic profile parameters: Time in Range
time frame: minimum 3 days to a maximum of 6 days of CGMS record
description: Mean time spent in the appropriate glycemic range in %
measure: Glycemic profile parameters: ADRR
time frame: minimum 3 days to a maximum of 6 days of CGMS record
description: Average of Daily Risk Ratio (ADRR) from CGMS glycaemia
measure: Glycemic profile parameters: CONGA
time frame: minimum 3 days to a maximum of 6 days of CGMS record
description: Continuous Overall Net Glycemic Action (CONGA) from CGMS glycaemia
measure: Glycemic profile parameters: hyperglycemia durations
time frame: minimum 3 days to a maximum of 6 days of CGMS record
description: hyperglycemia durations
measure: Glycemic profile parameters: hypoglycemia durations
time frame: minimum 3 days to a maximum of 6 days of CGMS record
description: hypoglycemia durations
measure: Glycemic profile parameters: mean glycemic value
time frame: minimum 3 days to a maximum of 6 days of CGMS record
description: mean glycemic value on relevant time interval
measure: Glycemic profile parameters: incremental AUC
time frame: minimum 3 days to a maximum of 6 days of CGMS record
description: incremental AUC calculated on relevant time interval
measure: Glycemic profile parameters: total AUC
time frame: minimum 3 days to a maximum of 6 days of CGMS record
description: total AUC calculated on relevant time interval, calculated using the trapezoid rule and including all area below the curve
measure: Glycemic profile parameters: kinetics
time frame: minimum 3 days to a maximum of 6 days of CGMS record
description: Daylong glycaemia kinetics
measure: Compliance parameters: mean SDS ingestion
time frame: maximum of 6 days of LogBook record
description: mean SDS ingestion by type of meal and per day
measure: Dietary intake evaluation
time frame: After 1 week intervention diet
description: Dietary record analysis, in g of macronutrient intake
measure: Dietary record evaluation
time frame: After 1 week intervention diet
description: Dietary record analysis, in % of total energy intake
measure: Charaterisation of acceptability to H-SDS diet in free living conditions
time frame: After 1 week intervention diet
description: Feedback questionnaire
arm group label: Diet A
arm group type: Active Comparator
description: Balanced diet high in Slowly Digestible Starch
arm group label: Diet B
arm group type: Placebo Comparator
description: Balanced diet low in Slowly Digestible Starch
intervention type: Other
intervention name: Balanced diet high in Slowly Digestible Starch
description: 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.
arm group label: Diet A
intervention type: Other
intervention name: Balanced diet low in Slowly Digestible Starch
description: 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.
arm group label: Diet B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Emmanuel DISSE, MD, PhD
role: Principal Investigator
affiliation: Centre de Recherche en Nutrition Humaine Rhône-Alpes
last name: Martine LAVILLE, MD, PhD
role: Study Chair
affiliation: Centre de Recherche en Nutrition Humaine Rhône-Alpes
facility: 
country: France
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No