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NCT Number: NCT04657367

Polish Registry of Diabetes (PolReD)

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.

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Key information

Conditions

Diabetes Body Weight Diabetes Mellitus Dysglycemia Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Research Centre, Medical University of Bialystok

Bialystok, Podlaskie Voivodeship, 15-276, Poland

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational study - registry

Other

Observational study - registry

Primary outcomes

  1. HbA1c

    Time frame: every 5 years

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

  2. Fasting glucose

    Time frame: every 5 years

    Fasting glucose concentration measured in plasma using the colorimetric method

  3. 2-hour glucose

    Time frame: every 5 years

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

  4. Fasting insulin

    Time frame: every 5 years

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

  5. Lean body mass

    Time frame: every 5 years

    Total lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)

  6. Fat mass

    Time frame: every 5 years

    Total body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)

  7. Visceral Adipose Tissue mass

    Time frame: every 5 years

    Visceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)

  8. Weight

    Time frame: every 5 years

    Total body weight measured using standardized scale

  9. Homeostatic model assessment for insulin resistance (HOMA-IR)

    Time frame: every 5 years

    Homeostatic model assessment for insulin resistance

  10. Homeostatic model assessment of beta cell function (HOMA-beta)

    Time frame: every 5 years

    Homeostatic model assessment of beta cell function

  11. VO2max

    Time frame: every 5 years

    Maximal oxygen consumption measured during cardio-pulmonary exercise test

  12. Triglycerides (TG)

    Time frame: every 5 years

    Serum triglycerides concentration measured using colorimetric method

  13. High-density lipoprotein cholesterol (HDL)

    Time frame: every 5 years

    Serum 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

  14. Low-density lipoprotein cholesterol (LDL)

    Time frame: every 5 years

    Serum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method

  15. Total cholesterol

    Time frame: every 5 years

    Serum total cholesterol concentration measured using colorimetric method

  16. Plasma metabolome

    Time frame: every 5 years

    plasma metabolites concentrations measured using untargeted metabolomics

  17. Skeletal muscle transcriptome

    Time frame: every 5 years

    skeletal muscle gene and smallRNA expressions measured using untargeted transcriptomics

  18. Skeletal muscle metabolome

    Time frame: every 5 years

    skeletal muscle metabolites concentrations measured using untargeted metabolomics

  19. Plasma microRNAs

    Time frame: every 5 years

    Expression of circulating smallRNA

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Registry information

Official study title

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

Acronym: PolReD

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Dec 8, 2020
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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