NCT03847701Completed
Cardio-metabolic and Inflammatory Impact of Starch Digestibility in Type 2 Diabetic Patients
Source: ClinicalTrials.gov · Last updated 1 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 53 (actual)
- First submitted
- 30 Jan 2019
- Start date
- 25 Jun 2019
- Primary completion date
- 15 Nov 2024
- Lead sponsor
- Mondelēz International, Inc.
- Diseases
- Type 2 diabetes
- NCT number
- NCT03847701
What you commit to
- Study type: Interventional
- Participants enrolled: 53
- From 25 Jun 2019 to the primary completion date, 15 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- 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…)
Age
- Women of childbearing age without an efficient contraceptive method according to the investigator
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre de Recherche en Nutrition Humaine Rhone-Alpes Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.