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

NCT03847701 | Completed

• 1 other identifier: KBE045
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Type2 Diabetes

Keywords

Slowly Digestible Starch; SDS; Type 2 diabetes; T2D; Glycemic response; Continuous Glucose Monitoring System; CGMS; Diet; MAGE; Mean Amplitude of Glucose Excursion

Outcome Measures

Primary Outcomes (1)

• MAGE comparison following 3 months of intake of a diet either high or low in SDS

  Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia

  Minimum 3 days to a maximum of 6 days of CGMS record

Secondary Outcomes (91)

• Glycemia iAUC characterisation of a standard challenge test (FlexMeal) during the first metabolic day

  5 hours post standard challenge test during visit 3

• Insulin iAUC characterisation of a standard challenge test (FlexMeal) during the first metabolic day

  5 hours post standard challenge test during visit 3

• GLP1 iAUC characterisation of a standard challenge test (FlexMeal) during the first metabolic day

  5 hours post standard challenge test during visit 3

• Inflammatory status comparison during the first metabolic day : CRPus concentration

  At a basal state during visit 3

• Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the first metabolic day : TNFa iAUC

  5 hours post standard challenge test during visit 3

Study Arms (2)

High in SDS

ACTIVE COMPARATOR

Balanced diet high in Slowly Digestible Starch

Other: Balanced diet high in Slowly Digestible Starch

Low in SDS

PLACEBO COMPARATOR

Balanced diet low in Slowly Digestible Starch

Other: Balanced diet low in Slowly Digestible Starch

Interventions

Balanced diet low in Slowly Digestible Starch OTHER

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.

Also known as: Diet B, L-SDS

Low in SDS

Balanced diet high in Slowly Digestible Starch OTHER

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.

Also known as: Diet A, H-SDS

High in SDS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient under legal protection measure
• Patient deprived of liberty by a court or an administrative decision
• 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

Sponsors & Collaborators

• Centre de Recherche en Nutrition Humaine Rhone-Alpe: collaborator
• Mondelēz International, Inc.: lead
• Biofortis Mérieux NutriSciences: collaborator

Study Sites (1)

Centre de Recherche en Nutrition Humaine Rhone-Alpes

Pierre-Bénite, 69310, France

Location

Related Publications (1)

• Chisbert M, Castell AL, Van Den Berghe L, Breyton AE, Feugier N, Cuerq C, Chikh K, Brack O, Laville M, Goux A, Meynier A, Vinoy S, Nazare JA. Optimizing glycemic variability in type 2 diabetes using simple dietary and culinary recommendations to modulate starch digestibility: a randomized controlled trial. Am J Clin Nutr. 2025 Dec;122(6):1591-1601. doi: 10.1016/j.ajcnut.2025.10.007. Epub 2025 Oct 13.

  PMID: 41092985 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Emmanuel DISSE, MD, PhD

  Centre de Recherche en Nutrition Humaine Rhône-Alpes

  PRINCIPAL INVESTIGATOR

• Martine LAVILLE, MD, PhD

  Centre de Recherche en Nutrition Humaine Rhône-Alpes

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Each diet will be labelled "Diet A" or "Diet B"
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each participant will be allocated to an intervention arm in a parallel design for 3 months of intervention

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 20, 2019
• Study Start: June 25, 2019
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)