Diabetes Registry Graz for Biomarker Research (GIRO)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Obesity and diabetes represent probably the most challenging threat to public health in the 21st century.
Despite well-controlled established cardiovascular risk factors, the residual risk in subjects with diabetes mellitus is significantly higher than the risk in those without the condition and it is well established that current risk prediction models for cardiovascular disease using established risk factors do not fully explain the future cardiovascular risk.
Therefore, biomarker for better risk stratification are needed, in particular in subjects with diabetes mellitus. Prospective cohorts, meticulously clinically phenotyping subjects, regularly following them and collecting biomarker samples is one key approach for finding new biomarker panels, that are predictive of treatment response and future micro- and macrovascular complications.
The Diabetes registry for Biomarker Research Graz was initiated in November 2015. Subjects with type 1 and type 2 diabetes, rare types of diabetes, obesity or dyslipidemia are recruited in the outpatient clinic for Diabetes, Lipid and Metabolic Disorders at the University Clinic Graz or in the Rehabilitation Center St. Radegund.
As of September 2021, 1250 subjects are recruited. Blood and urine samples samples are collected at baseline and at annual follow up visits as well as data on medical history, diagnoses and medication.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Caren Sourij, MD
- Email: caren.sourij@medunigraz.at
Study Contact Backup
- Name: Harald Sourij, MD
- Email: ha.sourij@medunigraz.at
Study Locations
-
-
-
Graz, Austria, 8010
- Recruiting
- Medical University of Graz
-
Contact:
- Caren Sourij, MD
- Email: caren.sourij@medunigraz.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 - 99 years
- Informed consent has to be given in written form
- At least one of the following diseases:
- Type 1 diabetes
- Type 2 diabetes
- Type 3 diabetes
- Maturity onset diabetes of young (MODY)
- Late onset diabetes of the adult (LADA)
- Adipositas (BMI > 30kg/m2)
- Lipid metabolism disorder
Exclusion Criteria:
- No written informed consent
- No willingness to participate in this registry
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Type 1 Diabetes
Patients with diagnosed type 1 diabetes mellitus
|
In this registry no intervention is carried out
|
|
Type 2 Diabetes
Patients with diagnosed type 2 diabetes mellitus
|
In this registry no intervention is carried out
|
|
Adipositas
Obese patients with a BMI > 30kg/m2
|
In this registry no intervention is carried out
|
|
Lipid metabolism disorder
Patients with disorder of lipid metabolism
|
In this registry no intervention is carried out
|
|
Type 3 Diabetes Mellitus
Patients with diagnosed type 3 diabetes mellitus
|
In this registry no intervention is carried out
|
|
Maturity onset diabetes of the young (MODY)
Patients with diagnosed MODY
|
In this registry no intervention is carried out
|
|
Late onset diabetes of the adult (LADA)
Patients with diagnosed LADA
|
In this registry no intervention is carried out
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biomarker identification
Time Frame: Over entire period of registry (20 years)
|
Identification of biomarker panels that allow prediction of future micro- and macrovascular disease and events. Changes of these biomarkers over time in a selected, defined cohort will be reported. |
Over entire period of registry (20 years)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biomarker validation
Time Frame: Over entire period of registry (20 years)
|
Validation of suggested biomarkers in the field of diabetes complications.
|
Over entire period of registry (20 years)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Harald Sourij, MD, Medical University of Graz
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-2015-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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