type 1 diabetes
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. T1D determined by either autoantibodies or based on clinical and historical data or both, with a disease duration of at least 35 years. 2. T1D with established diabetic autonomic neuropathy, evidenced by delayed gastric emptying and / or cardiovascular autonomic neuropathy, irrespective of diabetes duration. 3. Treated for T1D at any center in The Netherlands. 4. Subject has been able to read the patient information sheet, understands the study protocol and agrees to comply with it, had time to ask questions and get answers, and were willing to give signed informed consent.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Non-T1D. 2. Patients with a duration of T1D less than 35 years and without AN 3. On experimental medication or participating in other studies with conflicting goals and schedules 4. Diseases or conditions that the investigator/physician believes to be a contraindication to participate. 5. Unwilling to be informed on incidental findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: Materials to be collected in addition for this project: - extensive clinical evaluation of long-term glycaemic control, diabetes treatment, (history of) hypoglycaemia, clinical complications, including ophthalmologic examinations, hospital admissions, and -if present- auto-antibody status at diagnosis. Sources will be digital records and letter to GP*s. - questionnaires related to medical history including (previous) smoking status, previous surgery, family history, education, socio-economic situation, work, sport and leisure time activities, peer support, well-being, health-related quality of life, anxiety and depression, chronic fatigue. - (preferably) fasting blood draw for collection of: blood (serum, plasma) buffy coat for isolation of DNA (Illumina GSA beadchip, Illumina 440k methylation chip) RNA / gene expression - 2-hour post-breakfast urine collection. - available routine laboratory measurements from the previous 5 years (including haematology, HbA1c, liver enzymes, renal function, thyroid function, vitamins (incl. vitD and vitB12) and antibodies, as well as auto-antibodies at diagnosis). - AGE-reader measurements (AGE-reader) - picture of hands and feet | — |
Secondary
| Measure | Time frame |
|---|---|
| None | — |
Countries
Netherlands
Outcome results
None listed