NCT03847701

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Mondelēz International, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

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 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.

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.

Timeline

• Start date: 2019-06-25
• Primary completion: 2024-11-15
• Completion: 2024-11-15
• First posted: 2019-02-20
• Last updated: 2026-04-01

Locations

1 site across 1 country: France