Cardio-metabolic and Inflammatory Impact of Starch Digestibility in Type 2 Diabetic Patients (NCT03847701) | Clinical Trial Compass
CompletedNot Applicable
Cardio-metabolic and Inflammatory Impact of Starch Digestibility in Type 2 Diabetic Patients
France53 participantsStarted 2019-06-25
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 progra…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MAGE comparison following 3 months of intake of a diet either high or low in SDS
Timeframe: Minimum 3 days to a maximum of 6 days of CGMS record