Clinical trial

Polish Registry of Diabetes (PolReD)

Recruiting now · Not applicable · 1 countries · Registry ID NCT04657367

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

AgeNot listed to Not listed
SexAll
Healthy volunteersAccepted
ConditionDiabetes, Obesity, PreDiabetes, Dysglycemia

Full registry 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

Treatments and study arms

Observational study - registry

Other

Observational study - registry

Primary outcomes

HbA1cevery 5 years

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

Fasting glucoseevery 5 years

Fasting glucose concentration measured in plasma using the colorimetric method

2-hour glucoseevery 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 insulinevery 5 years

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

Lean body massevery 5 years

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

Fat massevery 5 years

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

Visceral Adipose Tissue massevery 5 years

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

Weightevery 5 years

Total body weight measured using standardized scale

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Clinical Research Centre, Medical University of Bialystok🇵🇱 Bialystok, Podlaskie Voivodeship, Poland
Lukasz Szczerbinski, MD, PhDContact
Adam Kretowski, Prof., MD, PhDPrincipal Investigator
Lukasz Szczerbinski, MD, PhDPrincipal Investigator