Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention (NCT03792685) | Clinical Trial Compass
CompletedNot Applicable
Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention
Poland150 participantsStarted 2009-09-24
Plain-language summary
The objectives of this trial are to assess the effects of interactions between genetic factors and diet with various macronutrient intake on the metabolic disorders, obesity and type 2 diabetes risk, prevention, development and progress.
Who can participate
Age range
18 Years – 65 Years
Sex
MALE
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:
* healthy men with normal body weight and with overweight/obesity
* men with metabolic syndrome, hypertension, type 2 diabetes newly diagnosed, or not treated with any medicines
* maintaining the usual diet and lifestyle throughout the study
Exclusion Criteria:
* infectious or acute diseases in the last 4 weeks before the study visits
* any medicines/dietary supplements consumption in the last 4 weeks before the study visits
* high level of daily physical activity
* the following any special diet or dietary patterns (vegetarian, high-fat etc.)
* the presence of any other significant disease which may affect the results (hormonal disorders, history of any surgeries on gastrointestinal tract, allergies known or suspected, heart failure, history of cancer, any kidney, pancrea and liver diseases, except non-alcoholic fatty liver)
* abusive alcohol consumption
* abusive coffee or energy drinks consumption
* drug consumption
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
The postprandial change and differences in blood glucose levels associated with investigated single nucleotide polymorphisms.
Timeframe: Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
2
The postprandial change and differences in serum insulin concentrations associated with investigated single nucleotide polymorphisms.
Timeframe: Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
3
The change and differences in postprandial Triglycerides (TGs) concentrations associated with investigated single nucleotide polymorphisms.
Timeframe: Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
4
The change and differences in postprandial Free Fatty Acids (FFAs) concentrations associated with investigated single nucleotide polymorphisms.
Timeframe: Fasting (time 0) and 30, 60, 120, 180, 240 minutes after meal intake.
5
The change and differences in postprandial energy expenditure levels associated with investigated single nucleotide polymorphisms.
Timeframe: Fasting (time 0) and 60, 120, 180, 240 minutes after meal intake.
6
The change and differences in postprandial substrates (carbohydrate, fat and protein) utilization levels associated with investigated single nucleotide polymorphisms.