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临床试验/NCT03847701
NCT03847701Unknown不适用

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

Mondelēz International, Inc.2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年6月25日最近更新:
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适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
MAGE comparison following 3 months of intake of a diet either high or low in SDS
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
18 Years 至 75 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

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

时间窗: Minimum 3 days to a maximum of 6 days of CGMS record

Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia

次要结局

  • 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)
  • 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)
  • Insulinemic impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day(5 hours post standard challenge test during visit 10)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Glycemic impacts characterisation of a standard challenge test (FlexMeal) during the second metabolic day(5 hours post standard challenge test during visit 10)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • GLP1 iAUC characterisation of a standard challenge test (FlexMeal) during the second metabolic day(5 hours post standard challenge test during visit 10)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Oxydative stress characterisation following the intake of a diet either high or low in SDS : MDA concentration(After 3 months consumption of the diet)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Compare Diabetes follow-up markers during the first metabolic day : Glycated Albumin concentration(At the basal state during visit 3)
  • 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)
  • 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)
  • 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))
  • Compare diabetes follow-up markers during the first metabolic day : HbA1c(At the basal state during visit 3)
  • 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)
  • Compare Diabetes follow-up markers during the first metabolic day : Fructosamine concentration(At the basal state during visit 3)
  • 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)
  • 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))
  • 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)
  • 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)
  • 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)
  • 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)
  • 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 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)
  • 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)
  • Characterisation of the percent of compliance to H-SDS diet in free living conditions(After 3 months consumption of the diet)
  • Anthropometry parameters characterisation during the first metabolic day : height(At baseline during visit 3)
  • Anthropometry parameters characterisation during the first metabolic day : body weight(At baseline during visit 3)
  • 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)
  • Anthropometry parameters characterisation following the 3 months consumption of a diet either high or low in SDS : waist circumference(At baseline during visit 10)
  • Body composition parameters characterisation during the first metabolic day: total body water(At baseline during visit 3)
  • Anthropometry parameters characterisation during the first metabolic day : hip circumference(At baseline during visit 3)
  • 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)
  • 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)
  • 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)
  • Anthropometry parameters characterisation during the first metabolic day : waist circumference(At baseline during visit 3)
  • 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)
  • 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)
  • Anthropometry parameters characterisation following the 3 months consumption of a diet either high or low in SDS : height(At baseline during visit 10)
  • Anthropometry parameters characterisation following the 3 months consumption of a diet either high or low in SDS : hip circumference(At baseline during visit 10)
  • Body composition parameters characterisation during the first metabolic day: body fat(At baseline during visit 3)
  • Body composition parameters characterisation during the first metabolic day: lean mass.(At baseline during visit 3)
  • 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 composition parameters characterisation following the 3 months consumption of a diet either high or low in SDS : lean mass(At baseline during visit 10)
  • 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)
  • Resting energy metabolism profile during the first metabolic day: Resting Metabolism Rate(At baseline during visit 3)
  • Characterisation of acceptability to H-SDS diet in free living conditions(After 3 months consumption of the diet, at visit 10)

研究者

发起方
Mondelēz International, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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