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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03847701

Enrollment

Registered

2019-02-20

Start date

2019-06-25

Completion date

2024-11-15

Last updated

2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief summary

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.

Interventions

OTHERBalanced 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.

OTHERBalanced 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

Each diet will be labelled "Diet A" or "Diet B"

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion 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 * 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 * Patient with hemoglobin pathology * Patient with medical history of hemoglobinopathies (thalassemia, drepanocytosis…) * Patient with past bariatric surgery * Patient with medical history of endocrine diseases who may interfere with glucose metabolism according to the investigator (such as hyperthyroidism, acromegaly, hypercorticism…) * Patient treated with anticoagulants * Patient with a pace-maker * 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 with clinical significant relevance 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 with a planned weight loss program during the study * Patient with severe eating disorders (e.g. anorexia nervosa, binge eating disorder and bulimia) according to the investigator * Patient without stable dietary habits or with specific diet (vegetarian, vegan, gluten-free…) according to the investigator * Patient who smokes more than 5 cigarettes per day * 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 * Adhesive plaster skin allergy * Claustrophobic patient * Patient willing to take the plane during the CGMS periods

Design outcomes

Primary

Measure	Time frame	Description
MAGE comparison following 3 months of intake of a diet either high or low in SDS	Minimum 3 days to a maximum of 6 days of CGMS record	Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia

Secondary

Measure	Time frame	Description
Glycemia iAUC characterisation of a standard challenge test (FlexMeal) during the first metabolic day	5 hours post standard challenge test during visit 3	Glycemia iAUC
Insulin iAUC characterisation of a standard challenge test (FlexMeal) during the first metabolic day	5 hours post standard challenge test during visit 3	Insulin iAUC
GLP1 iAUC characterisation of a standard challenge test (FlexMeal) during the first metabolic day	5 hours post standard challenge test during visit 3	GLP1 iAUC
Inflammatory status comparison during the first metabolic day : CRPus concentration	At a basal state during visit 3	CRPus
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	TNFa iAUC
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the first metabolic day : IL6 iAUC	5 hours post standard challenge test during visit 3	IL6 iAUC
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the first metabolic day : IL1Ra iAUC	5 hours post standard challenge test during visit 3	IL1Ra iAUC
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the first metabolic day : IL18 iAUC	5 hours post standard challenge test during visit 3	IL18 iAUC
Glycemic impacts comparison following the intake of a diet either high or low in SDS during the time course of the study	At a basal state during visit 3, visit 6 and visit 10	Glycemia concentration
Insulinemic impacts comparison following the intake of a diet either high or low in SDS during the time course of the study	At a basal state during visit 3, visit 6 and visit 10	Insulin concentration
Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : CRPus concentration	At a basal state during visit 3, visit 6 and visit 10	CRPus concentration
Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : TNFa concentration	At a basal state during visit 3, visit 6 and visit 10	TNFa concentration
Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : IL6 concentration	At a basal state during visit 3, visit 6 and visit 10	IL6 concentration
Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : IL1Ra concentration	At a basal state during visit V3, V6 and V10	IL1Ra concentration
Inflammatory impacts comparison following the intake of a diet either high or low in SDS during the time course of the study : IL18 concentration	At a basal state during visit 3, visit 6 and visit 10	IL18 concentration
Oxidative Stress comparison following the intake of a diet either high or low in SDS during the time course of the study : MDA concentration	At a basal state during visit 3, visit 6 and visit 10	Malonaldehyde : MDA concentration
Oxidative Stress comparison following the intake of a diet either high or low in SDS during the time course of the study : Urinary isoprostanes concentration	At a basal state during visit 3, visit 6 and visit 10	Urinary isoprostanes concentration
Cardiovascular risk markers comparison following the intake of a diet either high or low in SDS during the time course of the study : MCP1 concentration	At a basal state during visit 3, visit 6 and visit 10	MCP1 concentration
Cardiovascular risk markers comparison following the intake of a diet either high or low in SDS during the time course of the study : sICAM concentration	At a basal state during visit 3, visit 6 and visit 10	sICAM concentration
Cardiovascular risk markers comparison following the intake of a diet either high or low in SDS during the time course of the study : sVCAM concentration	At a basal state during visit 3, visit 6 and visit 10	sVCAM concentration
Glycemic impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day	5 hours post standard challenge test during visit 10	Glycemia iAUC
Insulinemic impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day	5 hours post standard challenge test during visit 10	Insulin iAUC
GLP1 iAUC characterisation of a standard challenge test (FlexMeal) during the second metabolic day	5 hours post standard challenge test during visit 10	GLP1 iAUC
Inflammatory impacts comparison following 3 months of intake of a diet either high or low in SDS : CRPus concentration	At a basal state during visit 10	CRPus concentration
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : TNFa iAUC	5 hours post standard challenge test during visit 10	TNFa iAUC
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL6 iAUC	5 hours post standard challenge test during visit 10	IL6 iAUC
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL1Ra iAUC	5 hours post standard challenge test during visit 10	IL1Ra iAUC
Inflammatory impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day : IL18 iAUC	5 hours post standard challenge test during visit 10	IL18 iAUC
Cardiovascular risk markers characterisation following the intake of a diet either high or low in SDS : MCP1 concentration	After 3 months consumption of the diet	MCP1 concentration
Cardiovascular risk markers characterisation following the intake of a diet either high or low in SDS : sICAM concentration	After 3 months consumption of the diet	sICAM concentration
Cardiovascular risk markers characterisation following the intake of a diet either high or low in SDS : sVCAM concentration	After 3 months consumption of the diet	sVCAM concentration
Oxydative stress characterisation following the intake of a diet either high or low in SDS : MDA concentration	After 3 months consumption of the diet	Malonaldehyde : MDA concentration
Oxydative stress characterisation following the intake of a diet either high or low in SDS : Urinary isoprostanes concentration	After 3 months consumption of the diet	Urinary isoprostanes concentration
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : MAGE	minimum 3 days to a maximum of 6 days of CGMS record	Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : MAGE	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days	Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : TIR	minimum 3 days to a maximum of 6 days of CGMS record	Time In Range (TIR) from CGMS glycaemia
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : TIR	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days	Time In Range (TIR) from CGMS glycaemia
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : CV	minimum 3 days to a maximum of 6 days of CGMS record	Coefficient of Variation (CV) from CGMS glycaemia
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : CV	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days	Coefficient of Variation (CV) from CGMS glycaemia
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : SD	minimum 3 days to a maximum of 6 days of CGMS record	Standard Deviation (SD) from CGMS glycaemia
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : SD	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days	Standard Deviation (SD) from CGMS glycaemia
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : MIME	minimum 3 days to a maximum of 6 days of CGMS record	Mean Indices of Meal Excursions (MIME) from CGMS glycaemia
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : MIME	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days	Mean Indices of Meal Excursions (MIME) from CGMS glycaemia
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : MODD	minimum 3 days to a maximum of 6 days of CGMS record	Mean Of Daily Differences (MODD) from CGMS glycaemia
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : MODD	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days	Mean Of Daily Differences (MODD) from CGMS glycaemia
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : CONGA	minimum 3 days to a maximum of 6 days of CGMS record	Continuous Overall Net Glycemic Action (CONGA) from CGMS glycaemia
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : CONGA	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days	Continuous Overall Net Glycemic Action (CONGA) from CGMS glycaemia
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : ADRR	minimum 3 days to a maximum of 6 days of CGMS record	Average Daily Risk Range (ADRR) from CGMS glycaemia
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : ADRR	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days	Average Daily Risk Range (ADRR) from CGMS glycaemia
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : LGBI	minimum 3 days to a maximum of 6 days of CGMS record	Low Blood Glucose Index (LGBI) from CGMS glycaemia
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : LGBI	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days	Low Blood Glucose Index (LGBI) from CGMS glycaemia
Glycemic profile parameters following the intake of a diet either high or low in SDS during the time course of the study : HGBI	minimum 3 days to a maximum of 6 days of CGMS record	High Blood Glucose Index (HGBI) from CGMS glycaemia
Glycemic profile parameters following the 3 months consumption of a diet either high or low in SDS : HGBI	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days	High Blood Glucose Index (HGBI) from CGMS glycaemia
Mean daylong incremental Area Under the Curve (iAUC), measured by CGMS, following the intake of a diet either high or low in SDS during the time course of the study	from 0 min to 360 min postprandial during the CGMS record periods (from visit 3 to visit 4, from visit 6 to visit 7 and from visit 9 to visit 10)	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.
Mean daylong total Area Under the Curve (tAUC), measured by CGMS, following the intake of a diet either high or low in SDS during the time course of the study	from 0 min to 360 min postprandial during the CGMS record periods (from visit 3 to visit 4, from visit 6 to visit 7 and from visit 9 to visit 10)	The tAUC will be calculated using the trapezoid rule.
Compare diabetes follow-up markers during the first metabolic day : HbA1c	At the basal state during visit 3	Hba1c concentration
Compare diabetes follow-up markers following the intake of a diet either high or low in SDS during the time course of the study : HbA1c concentration	At a basal state, during visit 3, visit 6 and visit 10	Hba1c
Compare diabetes follow-up markers following the 3 months consumption of a diet either high or low in SDS : HbA1c concentration	After 3 months consumption of the diet, at the basal state	Hba1c
Compare Diabetes follow-up markers during the first metabolic day : Fructosamine concentration	At the basal state during visit 3	Fructosamine
Compare Diabetes follow-up markers following the intake of a diet either high or low in SDS during the time course of the study : fructosamine concentration	At a basal state, during visit 3, visit 6 and visit 10	Fructosamine
Compare Diabetes follow-up markers following the 3 months consumption of a diet either high or low in SDS : Fructosamine concentration	After 3 months consumption of the diet, at the basal state	Fructosamine
Compare Diabetes follow-up markers during the first metabolic day : Glycated Albumin concentration	At the basal state during visit 3	Glycated albumin
Compare Diabetes follow-up markers following the intake of a diet either high or low in SDS during the time course of the study : glycated albumin concentration	At a basal state, during visit 3, visit 6 and visit 10	Glycated albumin
Compare Diabetes follow-up markers following the 3 months consumption of a diet either high or low in SDS : Glycated Albumin concentration	After 3 months consumption of the diet, at the basal state	Glycated albumin
Arterial Endothelial Function characterisation following the intake of a diet either high or low in SDS during the time course of the study : RHI	At a basal state during visit 4, visit 7 and visit 9	Reactive Hyperemia (RHI)
Arterial Endothelial Function characterisation following the intake of a diet either high or low in SDS during the time course of the study : AI	At a basal state during visit 4, visit 7 and visit 9	Augmentation Index (AI)
Arterial Endothelial Function characterisation following the intake of a diet either high or low in SDS during the time course of the study : HRV	At a basal state during visit 4, visit 7 and visit 9	Heart Rate Variability (HRV)
Anthropometry parameters characterisation during the first metabolic day : height	At baseline during visit 3	Height
Anthropometry parameters characterisation during the first metabolic day : body weight	At baseline during visit 3	body weight
Anthropometry parameters characterisation during the first metabolic day : waist circumference	At baseline during visit 3	waist circumference
Anthropometry parameters characterisation during the first metabolic day : hip circumference	At baseline during visit 3	hip circumference
Anthropometry parameters characterisation following the intake of a diet either high or low in SDS during the time course of the study : height	At baseline during visit 3, visit 6 and visit 10	Height
Anthropometry parameters characterisation following the intake of a diet either high or low in SDS during the time course of the study : body weight	At baseline during visit 3, visit 6 and visit 10	body weight
Anthropometry parameters characterisation following the intake of a diet either high or low in SDS during the time course of the study : waist circumference	At baseline during visit 3, visit 6 and visit 10	waist circumference
Anthropometry parameters characterisation following the intake of a diet either high or low in SDS during the time course of the study : hip circumference	At baseline during visit 3, visit 6 and visit 10	hip circumference
Anthropometry parameters characterisation following the 3 months consumption of a diet either high or low in SDS : height	At baseline during visit 10	Height
Anthropometry parameters characterisation following the 3 months consumption of a diet either high or low in SDS : body weight	At baseline during visit 10	body weight
Anthropometry parameters characterisation following the 3 months consumption of a diet either high or low in SDS : waist circumference	At baseline during visit 10	waist circumference
Anthropometry parameters characterisation following the 3 months consumption of a diet either high or low in SDS : hip circumference	At baseline during visit 10	hip circumference
Body composition parameters characterisation during the first metabolic day: total body water	At baseline during visit 3	Total body water measured by bioimpedancemetry
Body composition parameters characterisation during the first metabolic day: body fat	At baseline during visit 3	Body fat measured by bioimpedancemetry
Body composition parameters characterisation during the first metabolic day: lean mass.	At baseline during visit 3	Lean mass measured by bioimpedancemetry
Body composition parameters characterisation following the 3 months consumption of a diet either high or low in SDS : total body water	At baseline during visit 10	Total body water measured by bioimpedancemetry
Body composition parameters characterisation following the 3 months consumption of a diet either high or low in SDS : body fat	At baseline during visit 10	Body fat measured by bioimpedancemetry
Body composition parameters characterisation following the 3 months consumption of a diet either high or low in SDS : lean mass	At baseline during visit 10	Lean mass measured by bioimpedancemetry
Resting energy metabolism profile during the first metabolic day: Resting Metabolism Rate	At baseline during visit 3	Resting Metabolism Rate (RMR)
Resting energy metabolism profile following the 3 months consumption of a diet either high or low in SDS : Resting Metabolism Rate	At baseline during visit 10	Resting Metabolism Rate (RMR)
Diabetic glycemic variability characterisation following the 3 months consumption of a diet either high or low in SDS	after 3 months consumption of the diet, CGMS record for a minimum of 3 days to a maximum of 6 days	Percent of subjects reaching the target for HbA1C, TIR and CV
Level of physical activity characterisation following the intake of a diet either high or low in SDS during the time course of the study : IPAQ	After each CGMS record periods, ie : at visit 4, visit 7 and visit 10	International Physical Activity Questionnaire (IPAQ)
Characterisation of acceptability to H-SDS diet in free living conditions	After 3 months consumption of the diet, at visit 10	Feedback questionnaire
Characterisation of the percent of compliance to H-SDS diet in free living conditions	After 3 months consumption of the diet	Table of compliance in the volunteer's notebook. Subjects will have to fulfill it after each meal during the study period

Countries

France

Contacts

PRINCIPAL_INVESTIGATOREmmanuel DISSE, MD, PhD

Centre de Recherche en Nutrition Humaine Rhône-Alpes

STUDY_CHAIRMartine LAVILLE, MD, PhD