Type1diabetesGIRONCT05324488
Diabetes Registry Graz for Biomarker Research
An observational study of Type1diabetes and Type 2 Diabetes, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Type1diabetes, Type 2 Diabetes, Adiposity
- How many people
- 2,000 participants
- Where
- 1 siteAustria
- Study dates
- 21 Oct 2015to 1 Feb 2035
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with different types of diabetes as well as obesity and lipid metabolism disorder are observed in this registry.
Who may be able to join
- 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
Show all 10Show fewer
- Maturity onset diabetes of young (MODY)
- Late onset diabetes of the adult (LADA)
- Adipositas (BMI > 30kg/m2)
- Lipid metabolism disorder
Who cannot join
- No written informed consent
- No willingness to participate in this registry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Caren Sourij, MD contact
Harald Sourij, MD contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz
Graz, 8010
Caren Sourij, MD, caren.sourij@medunigraz.at
About this study
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.
Read the 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.
- Conditions
- Type1diabetes, Type 2 Diabetes, Adiposity
- Being tested
- No intervention
- Keywords
- cohort study
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
In this registry no intervention is carried out
| Study group | Role | What they receive |
|---|---|---|
| Type 1 Diabetes | Patients with diagnosed type 1 diabetes mellitus Receives: Other: No intervention | |
| Type 2 Diabetes | Patients with diagnosed type 2 diabetes mellitus Receives: Other: No intervention | |
| Adipositas | Obese patients with a BMI > 30kg/m2 Receives: Other: No intervention | |
| Lipid metabolism disorder | Patients with disorder of lipid metabolism Receives: Other: No intervention | |
| Type 3 Diabetes Mellitus | Patients with diagnosed type 3 diabetes mellitus Receives: Other: No intervention | |
| Maturity onset diabetes of the young (MODY) | Patients with diagnosed MODY Receives: Other: No intervention | |
| Late onset diabetes of the adult (LADA) | Patients with diagnosed LADA Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Over entire period of registry (20 years)
Secondary outcomes (1)
Biomarker validation
Validation of suggested biomarkers in the field of diabetes complications.
Measured: Over entire period of registry (20 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start21 Oct 2015
- Primary completion1 Jan 2035 (estimated)
- Study completion1 Feb 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harald Sourij, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324488
- Sponsor's protocol ID
- HS-2015-01
- Acronym
- GIRO
- Status last verified
- Jul 2023
- First submitted
- 29 Sep 2021
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Registry Graz for Biomarker Research
- ClinicalTrials.gov ID
- NCT05324488
- Acronym / sponsor ID
- GIRO / HS-2015-01
- Conditions
- Type1diabetes, Type 2 Diabetes, Adiposity
- Keywords
- cohort study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 21 Oct 2015 (actual)
- Primary completion
- 1 Jan 2035 (estimated)
- Study completion
- 1 Feb 2035 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes | – | Other: No interventionPatients with diagnosed type 1 diabetes mellitus |
| Type 2 Diabetes | – | Other: No interventionPatients with diagnosed type 2 diabetes mellitus |
| Adipositas | – | Other: No interventionObese patients with a BMI > 30kg/m2 |
| Lipid metabolism disorder | – | Other: No interventionPatients with disorder of lipid metabolism |
| Type 3 Diabetes Mellitus | – | Other: No interventionPatients with diagnosed type 3 diabetes mellitus |
| Maturity onset diabetes of the young (MODY) | – | Other: No interventionPatients with diagnosed MODY |
| Late onset diabetes of the adult (LADA) | – | Other: No interventionPatients with diagnosed LADA |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with different types of diabetes as well as obesity and lipid metabolism disorder are observed in this registry.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (2 listed)
- No written informed consent
- No willingness to participate in this registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionIn this registry no intervention is carried out | Other | Adipositas, Late onset diabetes of the adult (LADA), Lipid metabolism disorder, Maturity onset diabetes of the young (MODY), Type 1 Diabetes, Type 2 Diabetes, Type 3 Diabetes Mellitus |
Primary outcome
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.
1 secondary outcome
Biomarker validation
Time frame: Over entire period of registry (20 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caren Sourij, MD contact
Harald Sourij, MD contact
Harald Sourij, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type1diabetes and Type 2 Diabetes, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caren Sourij, MD (caren.sourij@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker identification (time frame: Over entire period of registry (20 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.