Status:
COMPLETED
Evaluation of 2 Diets With Different Starch Digestibility Profiles on Daily Glycemic Profile, in T2D 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
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 pati...
Detailed Description
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 pati...
Eligibility Criteria
Inclusion
- Patient able to understand the study information and providing written consents 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 6,5% and 8,5%
- Bi-therapy associating metformin and sitagliptin at stable dose for at least 1 month
- T2D volunteer without insulin therapy or GLP-1 analogues
- Patient with BMI ranging between 22 and 37 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 two weeks
- Patient not suffering from intolerance or allergy
- Patient regularly consuming products proposed in the study
- Patient regularly consuming 3 main meals per day
- Sedentary behavior or stable regular 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 assurance
Exclusion
- General 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
- Biological criteria:
- 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
- Other biological abnormality with clinical significant relevance according to the investigator
- Therapeutic and medical criteria:
- Patient with type 1 diabetes
- T2D treatment other than metformin and sitagliptin
- Patient with past bariatric surgery
- Patient with medical history of endocrine diseases who may interfere with glucose metabolism according to the investigator (such as thyroid dysfunction, acromegaly, hypercorticism…)
- 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 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 willing to lose weight
- Patient with eating disorders (e.g. anorexia nervosa and bulimia) according to the investigator
- Patient without stable dietary habits or with specific diet (vegetarian, vegan,…) according to the investigator
- Patient who smokes
- 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
- Patient consuming in the two previous months regularly corticoids, anorectics, adrenergic drugs, beta-blocking drugs, antiplatelet agent (like aspirin) or other drugs or supplement that should impact glucose metabolism (other than metformin or DPP4 inhibitor) in the investigator's opinion
- Adhesive plaster skin allergy
Key Trial Info
Start Date :
August 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03289494
Start Date
August 30 2017
End Date
July 24 2018
Last Update
May 27 2020
Active Locations (1)
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1
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Pierre-Bénite, France, 69310