Diabetes Registry Graz for Biomarker Research

NCT ID: NCT05324488

Last Updated: 2023-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-21

Study Completion Date

2035-02-01

Brief Summary

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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

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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.

Conditions

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Type1diabetes Type 2 Diabetes Adiposity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Type 1 Diabetes

Patients with diagnosed type 1 diabetes mellitus

No intervention

Intervention Type OTHER

In this registry no intervention is carried out

Type 2 Diabetes

Patients with diagnosed type 2 diabetes mellitus

No intervention

Intervention Type OTHER

In this registry no intervention is carried out

Adipositas

Obese patients with a BMI \> 30kg/m2

No intervention

Intervention Type OTHER

In this registry no intervention is carried out

Lipid metabolism disorder

Patients with disorder of lipid metabolism

No intervention

Intervention Type OTHER

In this registry no intervention is carried out

Type 3 Diabetes Mellitus

Patients with diagnosed type 3 diabetes mellitus

No intervention

Intervention Type OTHER

In this registry no intervention is carried out

Maturity onset diabetes of the young (MODY)

Patients with diagnosed MODY

No intervention

Intervention Type OTHER

In this registry no intervention is carried out

Late onset diabetes of the adult (LADA)

Patients with diagnosed LADA

No intervention

Intervention Type OTHER

In this registry no intervention is carried out

Interventions

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No intervention

In this registry no intervention is carried out

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harald Sourij, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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Medical University of Graz

Graz, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Caren Sourij, MD

Role: CONTACT

Harald Sourij, MD

Role: CONTACT

Facility Contacts

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Caren Sourij, MD

Role: primary

Other Identifiers

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HS-2015-01

Identifier Type: -

Identifier Source: org_study_id

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