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

Type2 Diabetes Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type2 Diabetes

• NCT number: NCT03847701
• Study type: Interventional
• Source: Mondelez International, Inc.
• Contact: Julie-Anne NAZARE, PhD
• Phone: +33 4 78 86 29 81
• Email: julie-anne.nazare@univ-lyon1.fr
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2019
• Completion date: December 2022