To identify novel (causal) risk factors, including biomarkers and genetic determinants for disease progression and (severe) diabetes complications in people with T2D, in order to develop new, more targeted and effective therapies that will improve…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Sleep disturbances (incl subtypes)
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint are diabetes progression and incident diabetes
complications, including microvascular complications (foot complications,
retinopathy, nephropathy), macrovascular complications (cardiovascular disease,
including myocardial infarction, angina pectoris, heart failure, stroke,
transient ischaemic attack and peripheral arterial disease) as well as
all-cause and cause-specific mortality.
Secondary outcome
Secondary endpoints include diabetes progression measured as anthropometrics,
metabolic status, prevalence and severity of non-alcoholic fatty liver disease
(NAFLD), medication use, psychological complications and quality of life.
Background summary
The morbidity and mortality risk of people with Type 2 diabetes (T2D) is twice
as high compared to persons with normal glucose tolerance. Currently, despite
treatment, clinical targets for cardiovascular risk factors are not achieved.
The Hoorn Diabetes Care System cohort (DCS) is a prospective cohort
representing a comprehensive dataset on the natural course of T2D. The cohort
consists of persons with T2D in primary care from the West-Friesland region of
the Netherlands. Enrolment in the cohort started in 1998 and this prospective
dynamic cohort currently holds >15.000 persons with T2D. In subgroups of the
cohort, biobanking and additional measurements have been performed to obtain
information on, for example, lifestyle, depression and genetics. The current
DCS biobank has contributed substantially to knowledge on determinants for
diabetes complications in people with T2D, including for example magnesium.
Metabolic risk factors of interest are however time dependent and are
influenced by treatment regimens, ageing and lifestyle. Because of recent
changes in the treatment of diabetes including a larger range of oral
hypoglycemic agents [2], to extent the current DCS biobank population sample
and to obtain follow up samples from participants, a new biobanking effort is
needed.
Study objective
To identify novel (causal) risk factors, including biomarkers and genetic
determinants for disease progression and (severe) diabetes complications in
people with T2D, in order to develop new, more targeted and effective therapies
that will improve care and reduce the burden of T2D, by extension of our
biobank.
Study design
Observational study
Study burden and risks
The time investments of the participants will be 1 hour and 15 minutes for one
visit to the research centre or a home visit. The visit will be combined with a
regular care visit, where possible, or otherwise scheduled separately from
care. The burden is limited, but includes the vena puncture that can cause
discomfort and can result in bruising that continues up to a few days after the
examinations.
In relation to the possibility of damage, the severity of potential harm and
the vulnerability of the participants it is concluded that the conduct of the
research involves a negligible risk to human participants and is therefore
justified.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- All adult newly diagnosed patients with T2D in the Hoorn DCS, who have not
yet been asked to participate in research;
- All DCS participants with T2D who have previously provided informed consent
to be contacted for research.
Exclusion criteria
• Unable to give written informed consent.
• Serious mental impairment i.e. preventing to understand the study protocol /
aim.
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 |
|---|---|
| ISRCTN | ISRCTN26257579 |
| CCMO | NL82907.018.23 |