Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/12/2016
Date assigned
06/01/2017
Last edited
04/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. Patients with type 2 diabetes have a high risk of cardiovascular (heart) disease and other complications which reduce their quality of life and require high levels of healthcare. The aim of this study is to examine the risk factors for diabetes complications, including biomarkers (molecules that can be measured in blood or tissue) and genetic information.

Who can participate?
Patients with type 2 diabetes in the Netherlands

What does the study involve?
Participants are asked permission to use their medical data for scientific research. The following information is collected: personal information, medication use, physical examination (body measurements, blood pressure, electrocardiography [heart electrical activity], retina [eye] photographs, vibration perception), questionnaires (socio-economic status, lifestyle, [family] history of disease, and well-being), and laboratory measurements. Participants also contribute urine and blood samples and DNA for genetic analysis. National databases like the municipality register are used for mortality (death rate) follow-up.

What are the possible benefits and risks of participating?
There is no direct benefit for the participants. In the future, the study results may lead to improvements in diabetes care. There are no risks of participating.

Where is the study run from?
VU University Medical Center (Netherlands)

When is the study starting and how long is it expected to run for?
November 2006 to January 2050

Who is funding the study?
1. Dutch Ministry of Health, Welfare and Sport (Netherlands)
2. Dutch University Hospitals (Netherlands)

Who is the main contact?
Dr Petra Elders

Trial website

http://parelsnoer.org/page/nl/

Contact information

Type

Scientific

Primary contact

Dr Petra Elders

ORCID ID

Contact details

Department of General Practice and Elderly Care
EMGO Institute for Health and Care Research
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

The Diabetes Pearl: diabetes biobanking in the Netherlands - an observational prospective cohort study

Acronym

Study hypothesis

Type 2 diabetes is associated with considerable comorbidity and severe complications, which reduce quality of life of the patients and require high levels of healthcare. The Diabetes Pearl is a large cohort of patients diagnosed with type 2 diabetes, covering different geographical areas in the Netherlands. The aim of this study is to create a research infrastructure that will allow the study of risk factors, including biomarkers and genetic determinants for severe diabetes complications.

Ethics approval

Ethics committee of the VU University Medical Center, 09/07/2009, ref: NL27783.029.09

Study design

Observational prospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Type 2 diabetes

Intervention

Baseline examinations were performed November 2009 - November 2016. To ensure quality of the data collected, standard operation procedures were developed and used in all 8 recruitment centers. From all patients who provide informed consent, the following information is collected: personal information, medication use, physical examination (antropometry, blood pressure, electrocardiography (ECG), retina photographs, ankle-brachial index, peripheral vibration perception), self-report questionnaire (socio-economic status, lifestyle, (family) history of disease, and psychosocial well-being), laboratory measurements (glucose, A1c, lipid profile, kidney function), biobank material (storage of urine and blood samples and isolated DNA). Follow-up of morbidity and mortality is planned through medical care providers and municipal registries. All gathered clinical data and biobank information is uploaded to a database for storage on a national level. Biobanks are maintained locally at all recruitment centers.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Diabetes complications and mortality:
1. Cardio-metabolic risk factors, assessed by anthropometry, blood pressure, ECG, ankle-brachial index, laboratory measurements, and self-report questionnaire at baseline
2. Retinopathy, assessed by retinal photography at baseline
3. Nephropathy, assessed with laboratory measurements at baseline
4. Neuropathy, assessed by peripheral vibration perception at baseline
Follow-up visits have not been planned yet. Follow-up of morbidity and mortality is done through medical care providers and municipal registries.

Secondary outcome measures

Quality of life and physical functioning, assessed by self-reported questionnaire at baseline

Overall trial start date

02/11/2006

Overall trial end date

01/01/2050

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients with type 2 diabetes mellitus according to WHO criteria
2. Treated by a Dutch University Clinic, an associated primary care clinic or transmural care system

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

7000

Participant exclusion criteria

None

Recruitment start date

01/11/2009

Recruitment end date

01/11/2016

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Center
Amsterdam
1081 HV
Netherlands

Sponsor information

Organisation

VU Universtity Medical Center

Sponsor details

De Boelelaan 1089a
Amsterdam
1081 BT
Netherlands

Sponsor type

University/education

Website

http://parelsnoer.org/page/nl/

Funders

Funder type

Government

Funder name

Ministerie van Volksgezondheid, Welzijn en Sport

Alternative name(s)

Dutch Ministry of Health, Welfare and Sport, VWS

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Netherlands

Funder name

Dutch University Hospitals

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The first results are expected in 2017.

IPD sharing plan
Data will not be made available. Proposals for collaborative research can be submitted to Dr Petra Elders.

Intention to publish date

31/12/2017

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

2012 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/23130988

Publication citations

Additional files

Editorial Notes