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Recruiting NCT04657367

Polish Registry of Diabetes (PolReD)

Observational Diabetes Obesity PreDiabetes Dysglycemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational study - registry.
Who it may be relevant to
Registry conditions: Diabetes, Obesity, PreDiabetes, Dysglycemia. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Polish Registry of Diabetes - PL: Polski Rejestr Diabetologiczny (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.

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

Primary outcome measures

  • HbA1c [Time frame: every 5 years]
  • Fasting glucose [Time frame: every 5 years]
  • 2-hour glucose [Time frame: every 5 years]
  • Fasting insulin [Time frame: every 5 years]
  • Lean body mass [Time frame: every 5 years]
  • Fat mass [Time frame: every 5 years]
  • Visceral Adipose Tissue mass [Time frame: every 5 years]
  • Weight [Time frame: every 5 years]
  • Homeostatic model assessment for insulin resistance (HOMA-IR) [Time frame: every 5 years]
  • Homeostatic model assessment of beta cell function (HOMA-beta) [Time frame: every 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Poland · 1 center
  • Clinical Research Centre, Medical University of Bialystok — Bialystok

Identifiers

NCT: NCT04657367 · R-I- 002/436/2019

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗