Diabetes Registry Graz for Biomarker Research

Type 2 Diabetes Clinical Trial

— GIRO  

Official title:

Diabetes Registry Graz for Biomarker Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05324488
• Other study ID #: HS-2015-01
• Status: Recruiting
• Start date: October 21, 2015
• Est. completion date: February 1, 2035

Study information

• Verified date: July 2023
• Source: Medical University of Graz
• Contact: Caren Sourij, MD
• Email: caren.sourij[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: February 1, 2035
• Est. primary completion date: January 1, 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Adiposity
• Diabetes Mellitus
• Type 2 Diabetes
• Type1diabetes

Intervention

Other:
• No intervention
In this registry no intervention is carried out

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Biomarker validation	Validation of suggested biomarkers in the field of diabetes complications.	Over entire period of registry (20 years)