Polish Registry of Diabetes (PolReD)

Overview

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.

Full Title of Study: “Polish Registry of Diabetes – PL: Polski Rejestr Diabetologiczny (PolReD)”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2030

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

  • Other: Observational study – registry
    • Observational study – registry

Arms, Groups and Cohorts

  • Diabetes
    • Patients with diagnosed diabetes
  • Prediabetes
    • Patients with diagnosed prediabetes defined as impaired fasting glucose and/or impaired glucose tolerance
  • Normoglycemia
    • Patients with normoglycemia, based on the OGTT – normal fasting glucose and normal glucose tolerance

Clinical Trial Outcome Measures

Primary Measures

  • HbA1c
    • Time Frame: every 5 years
    • Haemoglobin A1c measured by the high-performance liquid chromatography (HPLC) method
  • Fasting glucose
    • Time Frame: every 5 years
    • Fasting glucose concentration measured in plasma using the colorimetric method
  • 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
  • Fasting insulin
    • Time Frame: every 5 years
    • Fasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)
  • Lean body mass
    • Time Frame: every 5 years
    • Total lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
  • Fat mass
    • Time Frame: every 5 years
    • Total body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
  • Visceral Adipose Tissue mass
    • Time Frame: every 5 years
    • Visceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
  • Weight
    • Time Frame: every 5 years
    • Total body weight measured using standardized scale
  • Homeostatic model assessment for insulin resistance (HOMA-IR)
    • Time Frame: every 5 years
    • Homeostatic model assessment for insulin resistance
  • Homeostatic model assessment of beta cell function (HOMA-beta)
    • Time Frame: every 5 years
    • Homeostatic model assessment of beta cell function
  • VO2max
    • Time Frame: every 5 years
    • Maximal oxygen consumption measured during cardio-pulmonary exercise test
  • Triglycerides (TG)
    • Time Frame: every 5 years
    • Serum triglycerides concentration measured using colorimetric method
  • 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
  • Low-density lipoprotein cholesterol (LDL)
    • Time Frame: every 5 years
    • Serum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method
  • Total cholesterol
    • Time Frame: every 5 years
    • Serum total cholesterol concentration measured using colorimetric method
  • Plasma metabolome
    • Time Frame: every 5 years
    • plasma metabolites concentrations measured using untargeted metabolomics
  • Skeletal muscle transcriptome
    • Time Frame: every 5 years
    • skeletal muscle gene and smallRNA expressions measured using untargeted transcriptomics
  • Skeletal muscle metabolome
    • Time Frame: every 5 years
    • skeletal muscle metabolites concentrations measured using untargeted metabolomics
  • Plasma microRNAs
    • Time Frame: every 5 years
    • Expression of circulating smallRNA

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Medical University of Bialystok
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Lukasz Szczerbinski, MD, PhD, +48858318150, lukasz.szczerbinski@umb.edu.pl

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