Dietary Intervention to Improve Cardiometabolic Risk Profile in Individuals With Type 2 Diabetes (NCT05666843) | Clinical Trial Compass
CompletedNot Applicable
Dietary Intervention to Improve Cardiometabolic Risk Profile in Individuals With Type 2 Diabetes
Netherlands124 participantsStarted 2022-11-01
Plain-language summary
This is a randomized controlled trial to examine whether personalized guidance to increase the consumption of fiber rich food items according to the Dutch dietary guidelines, compared to usual care, improves health of individuals with type 2 diabetes.
Who can participate
Age range
18 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:
* Diagnosis of type 2 diabetes made by a medical doctor at least 6 months prior to study enrolment
* Adult
* Willing and able to follow dietary intervention
* Willing to participate in both intervention and control group
* Living at a reasonable distance from the research center at Wageningen University \& Research (WUR) (i.e.maximum of ± 1 hour away)
Exclusion Criteria:
* Currently treated with insulin therapy
* Recently (\< 6 months) or currently being under supervision of a dietician
* Pregnant or breast-feeding
* History of bariatric surgery, including gastric banding
* Current participation in a study with an investigational drug or dietary intervention
* Excessive alcohol consumption (more than 14 units for males/7 units for females per week) or drug use
* Clinical disorders that could interfere with the intervention (e.g. gastro-intestinal disorders, auto-immune diseases, psychiatric disorders, uncontrolled heart diseases, serious neurological disorders, renal failure or cancer)
* Not able to speak and understand the Dutch language
* No general practitioner
* Working at the department of Human Nutrition and Health at Wageningen University \& Research
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.