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NCT03847701Befejeződött

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. ápr. 1.

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Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
53 (tényleges)
Első benyújtás
2019. jan. 30.
Kezdés
2019. jún. 25.
Elsődleges befejezés
2024. nov. 15.
Fő szponzor
Mondelēz International, Inc.
NCT-szám
NCT03847701

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Bevont résztvevők: 53
  • 2019. jún. 25. és az elsődleges befejezés (2024. nov. 15.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • 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 past bariatric surgery
  • Patient treated with anticoagulants
  • Patient regularly consuming recreational drugs

Más betegség

  • Patient with type 1 diabetes, post pancreatectomy or post transplant diabetes, MODY diabetes, mitochondrial diabetes, iatrogenic diabetes
  • Patient with medical history of hemoglobinopathies (thalassemia, drepanocytosis…)
  • 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
  • Patient with severe eating disorders (e.g. anorexia nervosa, binge eating disorder and bulimia) according to the investigator
  • Adhesive plaster skin allergy

Laborértékek

  • Triglycerides > 4 g/L
  • LDL-cholesterol > 1.90 g/L
  • Hemoglobin < 120 mg/dL
  • Patient with hemoglobin pathology
  • Patient with medical history of endocrine diseases who may interfere with glucose metabolism according to the investigator (such as hyperthyroidism, acromegaly, hypercorticism…)

Életkor

  • Women of childbearing age without an efficient contraceptive method according to the investigator

Egyéb

  • 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)
  • CRP > 15 mg/L
  • eGRF (estimated glomerular filtration rate) < 45 ml/min
  • Other biological abnormality with clinical significant relevance according to the investigator
  • Patient with a pace-maker
  • Uncontrolled high blood pressure defined by Systolic blood pressure > 150 mmHg or Diastolic blood pressure > 100 mmHg
  • Pregnant women or willing to become pregnant or lactating women
  • Patient under a restrictive diet or with a planned weight loss program during the study
  • 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
  • Claustrophobic patient
  • Patient willing to take the plane during the CGMS periods

Kiket keres a vizsgálat

  • 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

Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Centre de Recherche en Nutrition Humaine Rhone-AlpesPierre-BéniteFranciaországIsmeretlen állapot

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