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Polish Registry of Diabetes (PolReD)

Polish Registry of Diabetes - PL: Polski Rejestr Diabetologiczny (PolReD)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04657367
Acronym
PolReD
Enrollment
10000
Registered
2020-12-08
Start date
2020-02-03
Completion date
2030-12-31
Last updated
2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Dysglycemia, Obesity, PreDiabetes

Keywords

diabetes registry, prediabetes registry

Brief summary

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.

Detailed description

The aim of this project is to create a registry of patients at risk of developing diabetes or already diagnosed with diabetes, 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. As part of the project, each patient will participate in one visit at the research center. During the visit, each patient will undergo a detailed medical interview regarding the current health condition, the course of previously diagnosed diseases, family history, physical activity and diet. In addition, venous blood will be taken for each patient, from which the basic metabolic parameters will be determined (including glucose, lipid profile, HbA1c, AST, ALT, GGTP, electrolytes, blood count with smear, presence of antibodies against beta-cell antigens, TSH, ACTH) and omics analyzes will be performed (including genotyping and sequencing of DNA, transcriptomics, metabolomics, proteomics and lipidomics). Additionally, from each patient, saliva, urine, stool sample, and skin and nasal swabs to assess the microbiome will be collected. Each patient will also receive a detailed body composition analysis using bioimpedance and densitometry (DXA) and grip strength analysis. Non-diabetic patients will also undergo an oral glucose load test (OGTT). In addition, patients who give additional consent will be able to participate in additional visits, including abdominal MR imaging with the assessment of liver steatosis, a biopsy of the vastus lateralis muscle, cardio-pulmonary exercise test, metabolic clamp (euglycemic - hyperinsulinemic) and glycemia assessment using the continuous glucose monitoring system ( CGM). As part of the project, we plan for follow-up each participant with re-visits in the study centre every five years, covering exactly the same schedule of visits as the patient will make the first time.

Interventions

Observational study - registry

Sponsors

Medical University of Bialystok
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
HbA1cevery 5 yearsHaemoglobin A1c measured by the high-performance liquid chromatography (HPLC) method
Fasting glucoseevery 5 yearsFasting glucose concentration measured in plasma using the colorimetric method
2-hour glucoseevery 5 yearsGlucose concentration at 2-hour of the oral glucose tolerance test, measured in plasma using the colorimetric method - only in non-diabetic subjects
Fasting insulinevery 5 yearsFasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)
Lean body massevery 5 yearsTotal lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Fat massevery 5 yearsTotal body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Visceral Adipose Tissue massevery 5 yearsVisceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Weightevery 5 yearsTotal body weight measured using standardized scale
Homeostatic model assessment for insulin resistance (HOMA-IR)every 5 yearsHomeostatic model assessment for insulin resistance
Homeostatic model assessment of beta cell function (HOMA-beta)every 5 yearsHomeostatic model assessment of beta cell function
VO2maxevery 5 yearsMaximal oxygen consumption measured during cardio-pulmonary exercise test
Triglycerides (TG)every 5 yearsSerum triglycerides concentration measured using colorimetric method
High-density lipoprotein cholesterol (HDL)every 5 yearsSerum high-density lipoprotein cholesterol (HDL) concentration measured using colorimetric method Serum high-density lipoprotein cholesterol (HDL) concentration measured using colorimetric method Serum high-density lipoprotein cholesterol (HDL) concentration measured using colorimetric meth
Low-density lipoprotein cholesterol (LDL)every 5 yearsSerum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method
Total cholesterolevery 5 yearsSerum total cholesterol concentration measured using colorimetric method
Plasma metabolomeevery 5 yearsplasma metabolites concentrations measured using untargeted metabolomics
Skeletal muscle transcriptomeevery 5 yearsskeletal muscle gene and smallRNA expressions measured using untargeted transcriptomics
Skeletal muscle metabolomeevery 5 yearsskeletal muscle metabolites concentrations measured using untargeted metabolomics
Plasma microRNAsevery 5 yearsExpression of circulating smallRNA

Countries

Poland

Contacts

Primary ContactLukasz Szczerbinski, MD, PhD
lukasz.szczerbinski@umb.edu.pl+48858318150

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026