Last updated: October 15, 2021
Sponsor: Mondelēz International, Inc.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Diabetes Mellitus, Type 2
Treatment
N/AClinical Study ID
NCT03847701
KBE045
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient able to understand the study information and providing written consent forhis/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 accordingto 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 carbohydratesintakes
- Sedentary behavior or stable predicted physical activity during the study
- Patient not presenting any disease during the medical examination / interview whichcould 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
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 ofanother study
- Volunteer that exceed the financial compensation allowed per year for participating inresearch 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 theinvestigator
- Patient with type 1 diabetes, post pancreatectomy or post transplant diabetes, MODYdiabetes, mitochondrial diabetes, iatrogenic diabetes
- T2D volunteer with any other anti-diabetic treatment other than metformin: insulintherapy, GLP-1 analogues, acarbose, sulphonylureas, repaglinide, SGLT2 agonists,…
- Patient consuming in the two previous months regularly corticoids, beta-blocking drugsor 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 glucosemetabolism 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 orDiastolic blood pressure > 100 mmHg
- Evidence of any other unstable or untreated clinically significant immunological,neoplasic, endocrine, haematological, gastrointestinal, hepatic, neurological orpsychiatric abnormalities or medical disease with clinical significant relevanceaccording to the investigator
- Pregnant women or willing to become pregnant or lactating women
- Women of childbearing age without an efficient contraceptive method according to theinvestigator
- Patient under a restrictive diet or with a planned weight loss program during thestudy
- Patient with severe eating disorders (e.g. anorexia nervosa, binge eating disorder andbulimia) 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 3alcoholic beverages per day is recognized as excessive. An alcoholic beverage is: 30mL 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
Study Design
Total Participants: 80
Study Start date:
June 25, 2019
Estimated Completion Date:
December 31, 2022
Study Description
Connect with a study center
Centre de Recherche en Nutrition Humaine Rhone-Alpes
Pierre-Bénite, 69310
FranceActive - Recruiting
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