Polish Registry of Diabetes (PolReD)
- Conditions
- DysglycemiaPreDiabetesDiabetesObesity
- Interventions
- Other: Observational study - registry
- Registration Number
- NCT04657367
- Lead Sponsor
- Medical University of Bialystok
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10000
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prediabetes Observational study - registry Patients with diagnosed prediabetes defined as impaired fasting glucose and/or impaired glucose tolerance Diabetes Observational study - registry Patients with diagnosed diabetes Normoglycemia Observational study - registry Patients with normoglycemia, based on the OGTT - normal fasting glucose and normal glucose tolerance
- Primary Outcome Measures
Name Time Method HbA1c every 5 years Haemoglobin A1c measured by the high-performance liquid chromatography (HPLC) method
2-hour glucose 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
Fat mass every 5 years Total body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Homeostatic model assessment for insulin resistance (HOMA-IR) every 5 years Homeostatic model assessment for insulin resistance
Fasting glucose every 5 years Fasting glucose concentration measured in plasma using the colorimetric method
Low-density lipoprotein cholesterol (LDL) every 5 years Serum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method
Plasma metabolome every 5 years plasma metabolites concentrations measured using untargeted metabolomics
Skeletal muscle metabolome every 5 years skeletal muscle metabolites concentrations measured using untargeted metabolomics
Fasting insulin every 5 years Fasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)
Total cholesterol every 5 years Serum total cholesterol concentration measured using colorimetric method
Visceral Adipose Tissue mass every 5 years Visceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Weight every 5 years Total body weight measured using standardized scale
Lean body mass every 5 years Total lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Homeostatic model assessment of beta cell function (HOMA-beta) every 5 years Homeostatic model assessment of beta cell function
VO2max every 5 years Maximal oxygen consumption measured during cardio-pulmonary exercise test
Triglycerides (TG) every 5 years Serum triglycerides concentration measured using colorimetric method
High-density lipoprotein cholesterol (HDL) 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 methSkeletal muscle transcriptome every 5 years skeletal muscle gene and smallRNA expressions measured using untargeted transcriptomics
Plasma microRNAs every 5 years Expression of circulating smallRNA
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Research Centre, Medical University of Bialystok
šµš±Bialystok, Podlaskie, Poland