Diabetes Registry Graz for Biomarker Research

Study Overview
=================
Brief Summary
-----------------
The Diabetes registry for biomarker research Graz is a prospective cohort-study including subjects with type 1 and type 2 diabetes, rare types of diabetes, obesity and dyslipidemia, aiming to collect data, blood and urine samples of all subjects on an annual basis.

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.

Official Title
-----------------
Diabetes Registry Graz for Biomarker Research

Conditions
-----------------
Type1diabetes, Type 2 Diabetes, Adiposity

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 1 Diabetes<br>Patients with diagnosed type 1 diabetes mellitus | Other: No intervention<br>* In this registry no intervention is carried out<br>|
| Type 2 Diabetes<br>Patients with diagnosed type 2 diabetes mellitus | Other: No intervention<br>* In this registry no intervention is carried out<br>|
| Adipositas<br>Obese patients with a BMI > 30kg/m2 | Other: No intervention<br>* In this registry no intervention is carried out<br>|
| Lipid metabolism disorder<br>Patients with disorder of lipid metabolism | Other: No intervention<br>* In this registry no intervention is carried out<br>|
| Type 3 Diabetes Mellitus<br>Patients with diagnosed type 3 diabetes mellitus | Other: No intervention<br>* In this registry no intervention is carried out<br>|
| Maturity onset diabetes of the young (MODY)<br>Patients with diagnosed MODY | Other: No intervention<br>* In this registry no intervention is carried out<br>|
| Late onset diabetes of the adult (LADA)<br>Patients with diagnosed LADA | Other: No intervention<br>* In this registry no intervention is carried out<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker identification | 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 | Validation of suggested biomarkers in the field of diabetes complications. | Over entire period of registry (20 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cohort study