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Polish Registry of Diabetes (PolReD)

ConditionsDiabetesObesityPreDiabetesDysglycemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMedical University of Bialystok

About this trial

The aim of this project is to create a registry of diabetic patients, containing a detailed clinical profile of each patient, along with omics data, which will be analyzed using artificial intelligence algorithms, and their results will be implemented in the form of new recommendations of care for high-risk patients and those already suffering from diabetes.

The study will be conducted prospectively. The project participants will be patients with diabetes, patients at high risk of developing diabetes and a control group of normoglycemic patients who will participate in study visits at the Clinical Research Center of the Medical University of Bialystok.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

patients with diagnosed diabetes (according to the American Diabetes Association criteria) - diabetes group

patients with diagnosed prediabetes (IFG and/or IGT) - prediabetes group

patients with normoglycemia (NFG and NGT) - normoglycemia group

informed consent

Disqualifiers

drug addiction

severe psychiatric disorders

patients with gestational diabetes mellitus

patients unable to give informed consent, legally incompetent or incapable to comply with the study terms and conditions

Trial population

The project participants will be patients with diabetes, patients at high risk of developing diabetes (prediabetes) and a control group of normoglycemic patients from Poland.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Observational study - registry

    Other intervention

    Observational study - registry

Treatment groups

10,000 Participants
are divided into 3 treatment groups
Group A: Diabetes1 intervention
Group B: Prediabetes1 intervention
Group C: Normoglycemia1 intervention

Trial outcomes

Primary outcomes

1

HbA1c

Haemoglobin A1c measured by the high-performance liquid chromatography (HPLC) method

Time frame
every 5 years
2

Fasting glucose

Fasting glucose concentration measured in plasma using the colorimetric method

Time frame
every 5 years
3

2-hour glucose

Glucose concentration at 2-hour of the oral glucose tolerance test, measured in plasma using the colorimetric method - only in non-diabetic subjects

Time frame
every 5 years
4

Fasting insulin

Fasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)

Time frame
every 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Bialystok

Lead sponsor

Source ClinicalTrials.gov
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