NCT05324488

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
105mo left

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Oct 2015Feb 2035

Study Start

First participant enrolled

October 21, 2015

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
12.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2035

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2035

Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

19.2 years

First QC Date

September 29, 2021

Last Update Submit

July 6, 2023

Conditions

Keywords

cohort study

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Biomarker validation

    Over entire period of registry (20 years)

Study Arms (7)

Type 1 Diabetes

Patients with diagnosed type 1 diabetes mellitus

Other: No intervention

Type 2 Diabetes

Patients with diagnosed type 2 diabetes mellitus

Other: No intervention

Adipositas

Obese patients with a BMI \> 30kg/m2

Other: No intervention

Lipid metabolism disorder

Patients with disorder of lipid metabolism

Other: No intervention

Type 3 Diabetes Mellitus

Patients with diagnosed type 3 diabetes mellitus

Other: No intervention

Maturity onset diabetes of the young (MODY)

Patients with diagnosed MODY

Other: No intervention

Late onset diabetes of the adult (LADA)

Patients with diagnosed LADA

Other: No intervention

Interventions

In this registry no intervention is carried out

AdipositasLate onset diabetes of the adult (LADA)Lipid metabolism disorderMaturity onset diabetes of the young (MODY)Type 1 DiabetesType 2 DiabetesType 3 Diabetes Mellitus

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with different types of diabetes as well as obesity and lipid metabolism disorder are observed in this registry.

You may qualify if:

  • 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

You may not qualify if:

  • No written informed consent
  • No willingness to participate in this registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, 8010, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urinary, plasma and serum samples are collected for future analysis

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Harald Sourij, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caren Sourij, MD

CONTACT

Harald Sourij, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2021

First Posted

April 12, 2022

Study Start

October 21, 2015

Primary Completion (Estimated)

January 1, 2035

Study Completion (Estimated)

February 1, 2035

Last Updated

July 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations