Evaluation of 2 Diets With Different Starch Digestibility Profiles on Daily Glycemic Profile, in T2D Patients

NCT03289494 | Completed

• 1 other identifier: KBE052
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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 patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS).

Conditions

Type2 Diabetes

Keywords

Slowly Digestible Starch; SDS; Type 2 diabetes; T2D; Glycemic response; Continuous Glucose Monitoring System; CGMS

Outcome Measures

Primary Outcomes (1)

• Mean postprandial incremental Area Under the Curve (iAUC), measured by CGMS

  The iAUC will be calculated using the trapezoid rule. The iAUC includes all area below the curve and above the fasting concentration, with any area beneath fasting being ignored.

  minimum 2h to maximum 6h postprandial periods and average value of minimum 3 days to a maximum of 6 days of CGMS record

Secondary Outcomes (20)

• Glycemic profile parameters: Minimum glycaemia

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

• Glycemic profile parameters: maximum glycaemia

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

• Glycemic profile parameters: Standard Deviation (SD) from CGMS glycaemia

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

• Glycemic profile parameters: Coefficient of Variation (CV) from CGMS glycaemia

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

• Glycemic profile parameters: MAGE

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

Study Arms (2)

Diet A

ACTIVE COMPARATOR

Balanced diet high in Slowly Digestible Starch

Other: Balanced diet high in Slowly Digestible Starch

Diet B

PLACEBO COMPARATOR

Balanced diet low in Slowly Digestible Starch

Other: Balanced diet low in Slowly Digestible Starch

Interventions

Balanced diet high in Slowly Digestible Starch OTHER

The carbohydrate present in the diet high in Slowly Digestible Starch were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during one week.

Diet A

Balanced diet low in Slowly Digestible Starch OTHER

The carbohydrate present in the diet low in Slowly Digestible Starch were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during one week.

Diet B

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 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

You may not qualify if:

• General criteria:
• 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
• 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

Sponsors & Collaborators

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

Study Sites (1)

Centre de Recherche en Nutrition Humaine Rhone-Alpe

Pierre-Bénite, 69310, France

Location

Related Publications (1)

• Breyton AE, Goux A, Lambert-Porcheron S, Meynier A, Sothier M, VanDenBerghe L, Brack O, Disse E, Laville M, Vinoy S, Nazare JA. Starch digestibility modulation significantly improves glycemic variability in type 2 diabetic subjects: A pilot study. Nutr Metab Cardiovasc Dis. 2021 Jan 4;31(1):237-246. doi: 10.1016/j.numecd.2020.08.010. Epub 2020 Aug 25.

  PMID: 32988721 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: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Each diet will be labelled "Diet A" or "Diet B"
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each subject will receive two independant weeks of diet intervention, in a crossover design

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 21, 2017
• Study Start: August 30, 2017
• Primary Completion: July 24, 2018
• Study Completion: July 24, 2018
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)