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Abstract
Aims
Carefully designed and established biobanks are considered one of the most essential resources to foster biomedical research as they provide cost-effective and rapid access to a vast variety of biological materials and related anthropometrics allowing for testing of various biomarkers as well as numerous original and pertinent bioclinical hypotheses related to human disease etiology and prognosis. The objective of the present study was to present the baseline data, design, and methods used for the establishment of the Vejle Diabetes Biobank. Further aims included assessment of the prevalence of diabetes and quality of diabetes treatment in a specified Danish region.
Methods
The Vejle Diabetes Biobank was established from 2007 to 2010 as a regional Biobank containing blood, DNA, and urine samples from patients with diabetes and a gender- and age-matched control population aged 25–75 years. Anthropometrics were obtained by physical examination, questionnaires, and interviews at the time of inclusion into the Biobank. The cohort was linked to the Danish Civil Registration System, the Danish National Patient Registry, and the Danish National Prescription Registry.
Results
In total, 4,255 nondiabetic individuals and 3,320 patients with diabetes were included. Type 2 diabetes (T2D) patients had a higher body mass index (30 kg/m2) than type 1 diabetes (T1D) patients (25 and 26 kg/m2 in women and men, respectively) and control subjects (25 and 27 kg/m2 in women and men, respectively). Fasting levels of plasma triglycerides and blood pressure were higher in T2D patients (1.5 mmol/L and 148/85 mmHg, respectively) compared with T1D patients (0.9 mmol/L and 139/81 mmHg, respectively), whereas glycated hemoglobin (HbA1c), plasma high density lipoprotein, low density lipoprotein, and total cholesterol were lower in T2D patients (51 mmol/mol, 1.2 mmol/L, 2.2 mmol/L, and 4.2 mmol/L, respectively) compared with findings in T1D patients (61 mmol/mol, 1.6 mmol/L, 2.3 mmol/L, and 4.4 mmol/L, respectively). At the time of inclusion into the Biobank, 56% of the T2D patients and 25% of T1D patients had an HbA1c <7% (53 mmol/mol). Only 28% and 34% of the T2D patients, respectively, reached treatment target for blood pressure and lipids.
Conclusion
The Vejle Diabetes Biobank represents one of the largest open diabetes case-control cohorts in Denmark. The Biobank invites collaborative investigations of diabetes and diabetes complication etiologies as well as studies of prognostic or predictive biomarkers.
Supplementary material
Information for patients
We kindly ask you to participate in the study: “Biobank for diabetes”.
“Biobank for diabetes”
The prevalence of diabetes has increased during the last years, particularly the type 2 diabetes. Genetic inheritance and environmental factors play a role for the development of type 2 diabetes. The aim of this study is:
To establish a biobank with blood samples and urine samples from 6,000 patients with diabetes and 6,000 persons without diabetes (control persons). The collection of data will last for 2–3 years.
To identify biochemical and molecular markers in blood and urine samples.
To compare the results of diabetes patients and control persons.
Hopefully to find the differences in lifestyle, environmental and inheritable factors, which causes diabetes and reduces lifetime due to diabetes-related complications.
To apply the knowledge in prevention and treatment of current and future patients.
What are the procedures on the day of examination, when you choose to register in the Biobank?
You only have to meet up once. You can choose Vejle, Kolding, Fredericia, or Horsens Hospital.
The examination will take place between 7.15 and 09.30 a.m. It will take about half an hour. Height, weight, waist and hip measurement, body fat percentage, blood pressure and blood glucose will be recorded, and you will get a copy of the data.
A number of samples will be taken for storage in the Biobank (all together about 125 mL blood).
Before the day of examination you will receive a container for the urine sample, please bring the urine sample on the day of examination.
Before the examination you will also receive a questionnaire about tobacco, alcohol, exercise etc. Please bring this as well on the day of examination.
After the examination you are offered some breakfast and coffee or tea. (If you need to take any medication, it will be possible at this time).
What to remember on the day of examination when registering in the Biobank
Please fast overnight, i.e. no eating, drinking (coffee, tea, milk, alcohol, juice etc.) or smoking from 10 p.m. the day before the examination. You are allowed 1–2 glasses of water from 10.00 p.m. until the examination takes place.
Please do not take medication for blood glucose regulation (insulin or tablets). This morning please try to avoid taking medication unless absolutely necessary until the examination has finished.
Please do not run or ride a bike on the day of examination.
Please remember to bring the urine sample mentioned above.
Please remember to bring the questionnaire mentioned above.
Moreover, you should live and eat as usually the last 3 days before examination.
What are the disadvantages/risks from participating in the study?
There is no physical risk or side effects from participating. The blood sampling might cause some temporary pain and bruise at the puncture site.
What are the advantages from participation in the study?
The study is expected to generate important information about the heritable differences in the Danish population causing diabetes and reducing the life span because of insufficient effect of the medical treatment and diabetes-related complications. Therefore, the study is useful in preventing new cases of diabetes and improving treatment for future diabetes patients.
The study might be able show if you belong to a group with higher risk of diabetes-related complications and therefore might have an extended need for treatment to avoid complications and premature death.
Can you be excluded from the study?
No, only if you choose to.
The study can be stopped if the funding discontinues. In that case all biological samples and data will be destructed.
Economy
The study was funded by the Danish Council for Independent Research/Medical Sciences, the Research Council of Vejle Hospital, the Department of Internal Medicine, Vejle Hospital, Vejle County, and the Danish Research Fund. The budget is 12 million DDK.
Your participation in the study is completely voluntary. You can withdraw your consent at any time. The paper: “The rights of a trial subject in a biomedical research project” is attached. It is elaborated by the National Committee for Health Research Ethics.
If you have any questions, you are welcome to contact the doctors.
Declaration of consent
For the study:
“Biobank for diabetes”
The aim of the study is to establish a biobank with samples of blood and urine, stored frozen for subsequent research. Do you permit that your blood and urine samples are collected in the biobank and subsequently used for identifying biochemical and heritable markers? (Please mark with a cross)
In this study we might find out that certain persons have specific changes in the biochemical markers increasing the risk for complications to diabetes (e.g. thrombus in the heart, diabetic eye disorder, or calcification).
If assuming that we can improve the treatment of your diabetes, do you want to get information about the findings in your particular blood samples? (Please mark with a cross)
You can change your decision about this information anytime by contacting:
Laboratory, Department of Clinical Biochemistry
Vejle Hospital
Kabbeltoft 25
7100 Vejle
Tel: 7 940 6506
If you have questions to the above, please contact:
Attachment 3: Questionnaire for patients
Acknowledgments
The project was funded by the Danish Council for Independent Research/Medical Sciences, the Research Council of Vejle Hospital, the Department of Internal Medicine, Vejle Hospital, Vejle County, the Danish Research Fund, the Lions Club International Denmark, and anonymous donations.
The authors would like to thank the laboratory technologists Britta Kristensen, Lene Juul Hansen, Annette Kaaris, Jan Johannsen, Merete Willumsen, Birgitte Henriksen, Camilla Davidsen, and Sara Egsgaard for their continued engagement and dedicated work.
Disclosure
The authors report no conflicts of interest in this work.