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NCT Number: NCT05324488

Diabetes Registry Graz for Biomarker Research

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz

Graz, 8010, Austria

Location status: Recruiting

Location contact

Caren Sourij, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

In this registry no intervention is carried out

Primary outcomes

  1. 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.

Secondary outcomes

  1. Biomarker validation

    Time frame: Over entire period of registry (20 years)

    Validation of suggested biomarkers in the field of diabetes complications.

Study contacts

Contact information is provided by the study sponsor or research team.

Caren Sourij, MD

CONTACT

[email protected]

Harald Sourij, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Acronym: GIRO

Important dates

Study start
2015
Primary completion
2035
Study completion
2035
First posted
Apr 12, 2022
Registry last updated
Jul 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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