Objective: To collect a broad array of clinical, behavioural, physical and biochemical parameters, to ensure that many clinical research questions or problems related to successful aging with T1D can be answered. Nevertheless, we have a priori…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Diabetic complications
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
None
Background summary
Rationale:
Successful and healthy ageing, in particular in people with T1D is related to
the propensity to be able to avoid secondary complications. There are two
important types of complications that differ in their way to impact the quality
of life:
a. microalbuminuria, high blood pressure, smoking, retinopathy and dysglycaemia
all are related to the development of vascular complications such as myocardial
infarction and stroke. For this reason, these complications are addressed in
the yearly check-up of diabetes health, and treated - if appropriate - with
ACE-inhibitors (microalbuminuria), blood pressure lowering agents in general,
lifestyle interventions, and statins (in case of hyperlipidaemia).
b. autonomic neuropathy appears to be a separate type of long-term
complications, and only very few risk factors for the development of AN have
been identified until now (19). In the yearly diabetes evaluation this is a
partly neglected complication. However, clinical evaluation of this type of
complications is warranted. Autonomic neuropathy is associated with many
complaints, severe fluctuations in glycaemic control, and a poor prognosis.
Study objective
Objective:
To collect a broad array of clinical, behavioural, physical and biochemical
parameters, to ensure that many clinical research questions or problems related
to successful aging with T1D can be answered. Nevertheless, we have a priori
postulated several research hypotheses, which we intend to solve with the
available data:
1. People with type 1 diabetes of >= 35 years* duration, who are clinically
free of complications, exhibit in contrast to subjects with clinically relevant
manifestations:
a. a larger degree of residual beta-cell function as evidenced by higher
urinary C-peptide secretion.
b. more beneficial biomarker composition of inflammatory, metabolic and genetic
biomarkers.
c. lower degree of genome-wide DNA methylation of genes thought to be relevant
for the development of inflammation and oxidative damage.
2. T1D subjects with clinically relevant manifestations of gastro-intestinal
and/or cardiovascular autonomic neuropathy exhibit in contrast to T1D subjects
clinically free of complications :
a. severe fluctuations of overall glycaemia.
b. reduced health-related quality of life, and impairments in daily life and
work.
c. specific alterations in the profiles of gastro-intestinal hormones, and
specific low-prevalence mutations in their genes and/ or their receptors.
Study design
Study design:
Cohort study
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness:
Single visit to research center.
Extensive questionnaires.
Venipuncture and 56 ml of blood draw.
Follow-up questionnaires by mail and/or digitally.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62401.042.17 |