Cardio-metabolic and Inflammatory Impact of Starch Digestibility in Type 2 Diabetic Patients
NCT ID: NCT03847701
Last Updated: 2021-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2019-06-25
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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High in SDS
Balanced diet high in Slowly Digestible Starch
Balanced diet high in Slowly Digestible Starch
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.
Low in SDS
Balanced diet low in Slowly Digestible Starch
Balanced diet low in Slowly Digestible Starch
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.
Interventions
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Balanced diet high in Slowly Digestible Starch
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.
Balanced diet low in Slowly Digestible Starch
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Centre de Recherche en Nutrition Humaine Rhone-Alpe
OTHER
Biofortis Mérieux NutriSciences
OTHER
Mondelēz International, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Emmanuel DISSE, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre de Recherche en Nutrition Humaine Rhône-Alpes
Martine LAVILLE, MD, PhD
Role: STUDY_CHAIR
Centre de Recherche en Nutrition Humaine Rhône-Alpes
Locations
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Centre de Recherche en Nutrition Humaine Rhone-Alpes
Pierre-Bénite, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Chisbert M, Castell AL, Van Den Berghe L, Breyton AE, Feugier N, Cuerq C, Chikh K, Brack O, Laville M, Goux A, Meynier A, Vinoy S, Nazare JA. Optimizing glycemic variability in type 2 diabetes using simple dietary and culinary recommendations to modulate starch digestibility: a randomized controlled trial. Am J Clin Nutr. 2025 Oct 13:S0002-9165(25)00611-2. doi: 10.1016/j.ajcnut.2025.10.007. Online ahead of print.
Other Identifiers
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KBE045
Identifier Type: -
Identifier Source: org_study_id