NCT Number: NCT04657367
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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Observational
Bialystok, Podlaskie Voivodeship, 15-276, Poland
Location status: Recruiting
Adam Kretowski, Prof., MD, PhD
PRINCIPAL_INVESTIGATOR
Lukasz Szczerbinski, MD, PhD
CONTACT
Lukasz Szczerbinski, MD, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Observational study - registry
Time frame: every 5 years
Haemoglobin A1c measured by the high-performance liquid chromatography (HPLC) method
Time frame: every 5 years
Fasting glucose concentration measured in plasma using the colorimetric method
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
Time frame: every 5 years
Fasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)
Time frame: every 5 years
Total lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Time frame: every 5 years
Total body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Time frame: every 5 years
Visceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Time frame: every 5 years
Total body weight measured using standardized scale
Time frame: every 5 years
Homeostatic model assessment for insulin resistance
Time frame: every 5 years
Homeostatic model assessment of beta cell function
Time frame: every 5 years
Maximal oxygen consumption measured during cardio-pulmonary exercise test
Time frame: every 5 years
Serum triglycerides concentration measured using colorimetric method
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
Time frame: every 5 years
Serum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method
Time frame: every 5 years
Serum total cholesterol concentration measured using colorimetric method
Time frame: every 5 years
plasma metabolites concentrations measured using untargeted metabolomics
Time frame: every 5 years
skeletal muscle gene and smallRNA expressions measured using untargeted transcriptomics
Time frame: every 5 years
skeletal muscle metabolites concentrations measured using untargeted metabolomics
Time frame: every 5 years
Expression of circulating smallRNA
Contact information is provided by the study sponsor or research team.
Medical University of Bialystok
Other
Polish Registry of Diabetes - PL: Polski Rejestr Diabetologiczny (PolReD)
Acronym: PolReD
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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