Status:
UNKNOWN
Cardio-metabolic and Inflammatory Impact of Starch Digestibility in Type 2 Diabetic Patients
Lead Sponsor:
Mondelēz International, Inc.
Collaborating Sponsors:
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Biofortis Mérieux NutriSciences
Conditions:
Type2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03847701
Start Date
June 25 2019
End Date
December 1 2022
Last Update
October 18 2021
Active Locations (1)
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1
Centre de Recherche en Nutrition Humaine Rhone-Alpes
Pierre-Bénite, France, 69310