Clinical trial NCT04657367: Polish Registry of Diabetes (PolReD)
Official title: Polish Registry of Diabetes - PL: Polski Rejestr Diabetologiczny (PolReD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes
Obesity
PreDiabetes
Dysglycemia
Keywords: diabetes registry
prediabetes registry
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The project participants will be patients with diabetes, patients at high risk of developing diabetes (prediabetes) and a control group of normoglycemic patients from Poland.

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.

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

Primary outcomes:
measure: HbA1c
timeFrame: every 5 years
measure: Fasting glucose
timeFrame: every 5 years
measure: 2-hour glucose
timeFrame: every 5 years
measure: Fasting insulin
timeFrame: every 5 years
measure: Lean body mass
timeFrame: every 5 years
measure: Fat mass
timeFrame: every 5 years
measure: Visceral Adipose Tissue mass
timeFrame: every 5 years
measure: Weight
timeFrame: every 5 years
measure: Homeostatic model assessment for insulin resistance (HOMA-IR)
timeFrame: every 5 years
measure: Homeostatic model assessment of beta cell function (HOMA-beta)
timeFrame: every 5 years
measure: VO2max
timeFrame: every 5 years
measure: Triglycerides (TG)
timeFrame: every 5 years
measure: High-density lipoprotein cholesterol (HDL)
timeFrame: every 5 years
measure: Low-density lipoprotein cholesterol (LDL)
timeFrame: every 5 years
measure: Total cholesterol
timeFrame: every 5 years
measure: Plasma metabolome
timeFrame: every 5 years
measure: Skeletal muscle transcriptome
timeFrame: every 5 years
measure: Skeletal muscle metabolome
timeFrame: every 5 years
measure: Plasma microRNAs
timeFrame: every 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bialystok
country: Poland
facility: Clinical Research Centre, Medical University of Bialystok
state: Podlaskie
Study officials:
References: