The goal of the *String-of-Pearls national academic biobank - the diabetes cohort* is to create a nation diabetes bio-databank, with DNA, urine and blood samples of 12.000 diabetespatients in combination with clinical data from the diabetes care in…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The associations of demographic, clinical, biochemical and genetic risk markers
factoren with diabetes complications.
Secondary outcome
na
Background summary
In 2007 the prevalence of type 2 diabetes in The Netherlands, based of GP
registries is 3,5%, and 14% for those over 65 years old. Due to the increasing
numbers of elderly people and the inreased prevalence of overweight and
obesity, the prevalence and the costs of type 2 diabetes will increase
dramatically in the near future. Treatment and care of diabetes complication
such as kidney failure, heart failure, and foot ulcers will be a growing burden
on the health care system, since duration of diabetes is the strongest risk
factor for diabetes complications and diabetes now occurs at younger ages.
Prevention of diabetes complications by the identification of modifyable risk
factors and better treatment strategies is the only way to control the costs.
Because complications such as kidney failure and ampuations of the lower
extremities occur relatively infrequent, large-scale studies are required to
assess the risk factors.
Study objective
The goal of the *String-of-Pearls national academic biobank - the diabetes
cohort* is to create a nation diabetes bio-databank, with DNA, urine and blood
samples of 12.000 diabetespatients in combination with clinical data from the
diabetes care in order to:
1. identify (genetic) risk markers for uncontroled diabetes and
(cardiovascular) diabetes complications,
2. evaluate the (cost-) effectiveness of therapies/medication,
3. provide descriptive statistics.
Study design
The Diabetes Pearl will first perform a baseline examination. The goal for the
future is to perform annual follow-up of cause-specific mortality,
cardiovascular events, and other diabetes complications. Preferably an annual
standardised medical examination will be performed to assess risk factors,
medication and (cardiovascular) complications.
In order to achive these goals, the 8 Dutch University medical center have
agreed on standardised measurements, blood and urine sampling, assessing a
minimal dataset and management of the bio-databank.
The minimal dataset:
1. Personal information (data for local use by care provider only) ID, name and
adress, gender, date of birth, general practitioner, pharmacist. date
consultation, etnicity, type of informed consent, date informed consent.
2 Biomaterials:
- fasting blood sampling (plasma, serum, DNA) Direct measurement of: glucose,
creatinin, total cholesterol, HDL cholesterol, triglycerides, HbA1c.
- Urine sample first void. Direct measurement of: dipstick leukocytes, dipstick
nitrite, creatinine and albumine.
3. Clinical examination:
- Medication
- ECG
- Ophthalmology
4. Physical examination:
- Antropometry
- Blood pressure
5. Questionniares:
- demography, smoking, alchohol consumption, medical history, family history
- Rose questionnaire (self report of AP, MI, stroke, claudication)
- EQ5D (quality of life)
Study burden and risks
Participants will give addtional blood and urine samples for the biobank when
attending the clinical for the diabetes care visit. They will be requested to
fill out a questionnaire (duration ~ 30 min). In addition consent will be asked
for access to their personal and medical data at their GP, pharmacy, hospital,
the Central Bureau of Statistics and the Municipal Regsitry.
van der Boechorststraat 7
Amsterdam 1081 BT
NL
van der Boechorststraat 7
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
Diagnsosis of type 2 diabetes mellitus according to the WHO 2006 criteria
Exclusion criteria
none
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 | NL27783.029.09 |