DiabetesPolReDNCT04657367
Polish Registry of Diabetes (PolReD)
An observational study of Diabetes and Obesity, run by Medical University of Bialystok at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Obesity, PreDiabetes
- What is being tested?
- Observational study - registry
- How many people
- 10,000 participants
- Where
- 1 sitePoland
- Study dates
- 3 Feb 2020to 31 Dec 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Clinical Research Centre, Medical University of Bialystok
Bialystok, Podlaskie Voivodeship, 15-276
Lukasz Szczerbinski, MD, PhD, +48 85 831 81 50, lukasz.szczerbinski@umb.edu.pl
Adam Kretowski, Prof., MD, PhD
About this study
Official title: Polish Registry of Diabetes - PL: Polski Rejestr Diabetologiczny (PolReD)
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.
Read the 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.
- Conditions
- Diabetes, Obesity, PreDiabetes, Dysglycemia
- Being tested
- Observational study - registry
- Keywords
- diabetes registry, prediabetes registry
- Medical subject headings
- Diabetes Mellitus, Obesity, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study - registryOther
Observational study - registry
| Study group | Role | What they receive |
|---|---|---|
| Diabetes | Patients with diagnosed diabetes Receives: Other: Observational study - registry | |
| Prediabetes | Patients with diagnosed prediabetes defined as impaired fasting glucose and/or impaired glucose tolerance Receives: Other: Observational study - registry | |
| Normoglycemia | Patients with normoglycemia, based on the OGTT - normal fasting glucose and normal glucose tolerance Receives: Other: Observational study - registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Haemoglobin A1c measured by the high-performance liquid chromatography (HPLC) method
Measured: every 5 years
Fasting glucose
Fasting glucose concentration measured in plasma using the colorimetric method
Measured: every 5 years
2-hour glucose
Glucose concentration at 2-hour of the oral glucose tolerance test, measured in plasma using the colorimetric method - only in non-diabetic subjects
Measured: every 5 years
Fasting insulin
Fasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)
Measured: every 5 years
Lean body mass
Total lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Measured: every 5 years
Fat mass
Total body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Measured: every 5 years
Visceral Adipose Tissue mass
Visceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Measured: every 5 years
Weight
Total body weight measured using standardized scale
Measured: every 5 years
Homeostatic model assessment for insulin resistance (HOMA-IR)
Homeostatic model assessment for insulin resistance
Measured: every 5 years
Homeostatic model assessment of beta cell function (HOMA-beta)
Homeostatic model assessment of beta cell function
Measured: every 5 years
VO2max
Maximal oxygen consumption measured during cardio-pulmonary exercise test
Measured: every 5 years
Triglycerides (TG)
Serum triglycerides concentration measured using colorimetric method
Measured: every 5 years
High-density lipoprotein cholesterol (HDL)
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
Measured: every 5 years
Low-density lipoprotein cholesterol (LDL)
Serum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method
Measured: every 5 years
Total cholesterol
Serum total cholesterol concentration measured using colorimetric method
Measured: every 5 years
Plasma metabolome
plasma metabolites concentrations measured using untargeted metabolomics
Measured: every 5 years
Skeletal muscle transcriptome
skeletal muscle gene and smallRNA expressions measured using untargeted transcriptomics
Measured: every 5 years
Skeletal muscle metabolome
skeletal muscle metabolites concentrations measured using untargeted metabolomics
Measured: every 5 years
Plasma microRNAs
Expression of circulating smallRNA
Measured: every 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start3 Feb 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657367
- Sponsor's protocol ID
- R-I- 002/436/2019
- Acronym
- PolReD
- Status last verified
- Nov 2024
- First submitted
- 1 Dec 2020
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polish Registry of Diabetes - PL: Polski Rejestr Diabetologiczny (PolReD)
- ClinicalTrials.gov ID
- NCT04657367
- Acronym / sponsor ID
- PolReD / R-I- 002/436/2019
- Conditions
- Diabetes, Obesity, PreDiabetes, Dysglycemia
- Keywords
- diabetes registry, prediabetes registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diabetes | – | Other: Observational study - registryPatients with diagnosed diabetes |
| Prediabetes | – | Other: Observational study - registryPatients with diagnosed prediabetes defined as impaired fasting glucose and/or impaired glucose tolerance |
| Normoglycemia | – | Other: Observational study - registryPatients with normoglycemia, based on the OGTT - normal fasting glucose and normal glucose tolerance |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study - registryObservational study - registry | Other | Diabetes, Normoglycemia, Prediabetes |
Primary outcome
HbA1c
Time frame: every 5 years
Haemoglobin A1c measured by the high-performance liquid chromatography (HPLC) method
Fasting glucose
Time frame: every 5 years
Fasting glucose concentration measured in plasma using the colorimetric method
2-hour glucose
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
Fasting insulin
Time frame: every 5 years
Fasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)
Lean body mass
Time frame: every 5 years
Total lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Fat mass
Time frame: every 5 years
Total body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Visceral Adipose Tissue mass
Time frame: every 5 years
Visceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Weight
Time frame: every 5 years
Total body weight measured using standardized scale
Homeostatic model assessment for insulin resistance (HOMA-IR)
Time frame: every 5 years
Homeostatic model assessment for insulin resistance
Homeostatic model assessment of beta cell function (HOMA-beta)
Time frame: every 5 years
Homeostatic model assessment of beta cell function
VO2max
Time frame: every 5 years
Maximal oxygen consumption measured during cardio-pulmonary exercise test
Triglycerides (TG)
Time frame: every 5 years
Serum triglycerides concentration measured using colorimetric method
High-density lipoprotein cholesterol (HDL)
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
Low-density lipoprotein cholesterol (LDL)
Time frame: every 5 years
Serum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method
Total cholesterol
Time frame: every 5 years
Serum total cholesterol concentration measured using colorimetric method
Plasma metabolome
Time frame: every 5 years
plasma metabolites concentrations measured using untargeted metabolomics
Skeletal muscle transcriptome
Time frame: every 5 years
skeletal muscle gene and smallRNA expressions measured using untargeted transcriptomics
Skeletal muscle metabolome
Time frame: every 5 years
skeletal muscle metabolites concentrations measured using untargeted metabolomics
Plasma microRNAs
Time frame: every 5 years
Expression of circulating smallRNA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Obesity, run by Medical University of Bialystok at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lukasz Szczerbinski, MD, PhD (+48858318150, lukasz.szczerbinski@umb.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: every 5 years). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.