Patients With a Type A or B Behaviour Profile Clinical Trial
— DiatolepsyOfficial title:
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
| NCT number | NCT02080741 |
| Other study ID # | CHAUVET-GELINIER APJ 2013 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 23, 2014 |
| Verified date | February 2024 |
| Source | Centre Hospitalier Universitaire Dijon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 57 |
| Est. completion date | |
| Est. primary completion date | May 29, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de DIJON | Dijon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire Dijon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Complications of diabetes (Nephropathy, Retinopathy, Neuropathy, Coronaropathy) | Baselines | ||
| Other | Scores on psychiatric/psychological scales | Baselines | ||
| Other | Analysis of the specific psychological interview EMIC | Baselines | ||
| Primary | Telomere length | Baselines | ||
| Secondary | Level of expression of candidate genes | Baselines |