Diabetes Registry Graz for Biomarker Research

Recruiting

• Conditions: Type 2 Diabetes; Type1diabetes; Adiposity
• Interventions: Other: No intervention

• Registration Number: NCT05324488
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study Start: 2015-10-21
• Study First Submitted: 2021-09-29
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-12
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-07
• Primary Completion: 2035-01-01
• Study Completion: 2035-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Maturity onset diabetes of the young (MODY)	No intervention	Patients with diagnosed MODY
Late onset diabetes of the adult (LADA)	No intervention	Patients with diagnosed LADA
Type 3 Diabetes Mellitus	No intervention	Patients with diagnosed type 3 diabetes mellitus
Adipositas	No intervention	Obese patients with a BMI \> 30kg/m2
Type 2 Diabetes	No intervention	Patients with diagnosed type 2 diabetes mellitus
Type 1 Diabetes	No intervention	Patients with diagnosed type 1 diabetes mellitus
Lipid metabolism disorder	No intervention	Patients with disorder of lipid metabolism

Primary Outcome Measures

Name	Time	Method
Biomarker identification	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 Outcome Measures

Name	Time	Method
Biomarker validation	Over entire period of registry (20 years)	Validation of suggested biomarkers in the field of diabetes complications.

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria