Study in Leucocytes From Patients With Type 1 and Type 2 Diabetes Genetic Markers of Inflammation… (NCT02080741) | Clinical Trial Compass
TerminatedNot Applicable
Study in Leucocytes From Patients With Type 1 and Type 2 Diabetes Genetic Markers of Inflammation and Oxidative Stress (TÉLOMÈRES/ CANDIDATE GENES) According to the Type A or Type B Behavior Profile
Stopped: lack of inclusion
France57 participantsStarted 2014-09-23
Plain-language summary
This study will include 100 patients with Type 1 and Type 2 diabetes, split into 2 groups of 50 patients according to their behaviour type, and their adaptation to different factors of stress encountered in their lives:
* the first group will consist of patients with a characteristic Type A behaviour profile, that is to say patients with a "proactive, impatient" behaviour pattern
* the second group will consist of patients with a characteristic Type B behaviour profile that is to say patients with a "calm, slow" behaviour pattern The objective is to know if the different behaviour patterns are associated with distinct biological markers likely to influence the evolution of the diabetes.
Participation in this study will be approximately 1h30, patients will participate ONCE ONLY:
1. they will answer simple questions about their disease and then complete 3 questionnaires each with 14 items.
2. they will meet a clinical psychologist for an interview lasting approximately 45 minutes recorded on an audio recorder. The consultation will be used to seek links between the psyche and the disease.
3. they will provide one blood sample of 12 ml (equivalent to a soup spoon) drawn in the morning.
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:
* Patients who have provided written informed consent
* Patients with type 1 or type 2 diabetes
* Patient admitted for a consultation, as out or in-patients to the Endocrinology-Diabetology-Metabolic diseases department of Dijon CHU
* Patient \> 18 years
* Patient with either a characteristic Type A behaviour profile (Bortner \> 210), or a characteristic Type B behaviour profile (Bortner\<154)
Exclusion Criteria:
* Persons not covered by national health insurance
* Adults under guardianship or wards of court or not intellectually independent
* Patients without diabetes
* Patients with a mixed A/B behaviour profile (154\< Bortner score \<210)
* Pregnant or breast-feeding women
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.