Clinical trial NCT05324488: Diabetes Registry Graz for Biomarker Research
Official title: Diabetes Registry Graz for Biomarker Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type1diabetes
Type 2 Diabetes
Adiposity
Keywords: cohort study
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with different types of diabetes as well as obesity and lipid metabolism disorder are observed in this registry.

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.

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

Primary outcomes:
measure: Biomarker identification
timeFrame: Over entire period of registry (20 years)
Secondary outcomes:
measure: Biomarker validation
timeFrame: Over entire period of registry (20 years)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Harald Sourij, MD
role: PRINCIPAL_INVESTIGATOR
References: