Cardio-metabolic and Inflammatory Impact of Starch Digestibility in Type 2 Diabetic Patients

Mondelez International

Status: Unknown

Conditions: Type2 Diabetes

Treatments: Other: Balanced diet low in Slowly Digestible Starch; Other: Balanced diet high in Slowly Digestible Starch

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03847701

KBE045

Details and patient eligibility

About

This is a monocentric, randomized, single-blind and controlled study with a parallel design (2 arms). The research hypothesis is that the diet high in Slow Digestible Starch (SDS) content (H-SDS) will lower the daylong glycemic response and improve the glycemic control just as metabolic, inflammatory, cardiovascular and oxidative stress parameters in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS). The hypothesis is that these differences in glycemic response and in metabolic, inflammatory, cardiovascular and oxidative stress parameters response can be observed after 3 months of diet.

Full description

This is a monocentric, randomized, single-blind and controlled study with a parallel design (2 arms). The research hypothesis is that the diet high in Slow Digestible Starch (SDS) content (H-SDS) will lower the daylong glycemic response and improve the glycemic control just as metabolic, inflammatory, cardiovascular and oxidative stress parameters in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS). The hypothesis is that these differences in glycemic response and in metabolic, inflammatory, cardiovascular and oxidative stress parameters response can be observed after 3 months of diet.

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient able to understand the study information and providing written consent 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 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 under legal protection measure
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

High in SDS

Active Comparator group

Description:

Balanced diet high in Slowly Digestible Starch

Treatment:

Other: Balanced diet high in Slowly Digestible Starch

Low in SDS

Placebo Comparator group

Description:

Balanced diet low in Slowly Digestible Starch

Treatment:

Other: Balanced diet low in Slowly Digestible Starch