PROTeIn-rich Meals to Control Glucose (NCT06382480) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
PROTeIn-rich Meals to Control Glucose
Germany30 participantsStarted 2024-04-12
Plain-language summary
The overall aim is to identify the dietary pattern for prevention and treatment of type 2 diabetes. The specific aim of this pilot project is to compare effects of two diets with different diurnal distribution of carbohydrates and protein on the glucose metabolism in subjects with prediabetes and type 2 diabetes and its effects on inflammatory status.
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:
* Prediabetes (fasting blood sugar 100-125 mg/dl)
* Diabetes type 2 (fasting blood sugar \>126 mg/dl)
* Overweight and obesity (BMI 25-50 kg/m2)
Exclusion Criteria:
* Other diabetes types
* Insulin treatment
* Shift work
* Weight changes \>5% within past 3 months
* Systemic glucocorticoid therapy
* Systemic infections
* Severe anemia
* High blood pressure (\>180/110 mmHg)
* Endocrinologic, liver and heart disorders
* Immune diseases
* Thyroid dysfunction
* Heart attack or stroke
* Cancer in the last 2 years
* Eating disorders, food intolerance/allergy, addiction disorders, digestive disorders intestinal, liver, cardiovascular diseases
* Hereditary or acquired coagulation disorders
* Non-interruptible intake of blood thinners (anticoagulants)
* Specific diets, intermittent fasting
* Pregnancy or breastfeeding
* Severe internal or psychiatric disorders or other conditions and drugs therapy that might influence the outcome of the study
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.