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Polish Registry of Diabetes (PolReD) (PolReD)

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ClinicalTrials.gov Identifier: NCT04657367
Recruitment Status : Recruiting
First Posted : December 8, 2020
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
Medical University of Bialystok

Study Description
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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.


Condition or disease Intervention/treatment
Diabetes Obesity PreDiabetes Dysglycemia Other: Observational study - registry

Detailed Description:

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.

As part of the project, each patient will take part 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 two years, covering exactly the same schedule of visits as the patient will make the first time.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Polish Registry of Diabetes - PL: Polski Rejestr Diabetologiczny (PolReD)
Actual Study Start Date : February 3, 2020
Estimated Primary Completion Date : December 31, 2099
Estimated Study Completion Date : December 31, 2099
Groups and Cohorts
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Group/Cohort Intervention/treatment
Diabetes
Patients with diagnosed diabetes
 Other: Observational study - registry
Observational study - registry
Prediabetes
Patients with diagnosed prediabetes defined as impaired fasting glucose and/or impaired glucose tolerance
 Other: Observational study - registry
Observational study - registry
Normoglycemia
Patients with normoglycemia, based on the OGTT - normal fasting glucose and normal glucose tolerance
 Other: Observational study - registry
Observational study - registry


Outcome Measures
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Primary Outcome Measures :
  1. HbA1c [ Time Frame: 2 years ]
    Haemoglobin A1c measured by the high-performance liquid chromatography (HPLC) method

  2. Fasting glucose [ Time Frame: 2 years ]
    Fasting glucose concentration measured in plasma using the colorimetric method

  3. 2-hour glucose [ Time Frame: 2 years ]
    Glucose concentration at 2-hour of the oral glucose tolerance test, measured in plasma using the colorimetric method - only in non-diabetic subjects

  4. Fasting insulin [ Time Frame: 2 years ]
    Fasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)

  5. Lean body mass [ Time Frame: 2 years ]
    Total lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)

  6. Fat mass [ Time Frame: 2 years ]
    Total body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)

  7. Visceral Adipose Tissue mass [ Time Frame: 2 years ]
    Visceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)

  8. Weight [ Time Frame: 2 years ]
    Total body weight measured using standardized scale

  9. Homeostatic model assessment for insulin resistance (HOMA-IR ) [ Time Frame: 2 years ]
    Homeostatic model assessment for insulin resistance

  10. Homeostatic model assessment of beta cell function (HOMA-beta) [ Time Frame: 2 years ]
    Homeostatic model assessment of beta cell function

  11. VO2max [ Time Frame: 2 years ]
    Maximal oxygen consumption measured during cardio-pulmonary exercise test

  12. Triglycerides (TG) [ Time Frame: 2 years ]
    Serum triglycerides concentration measured using colorimetric method

  13. High-density lipoprotein cholesterol (HDL) [ Time Frame: 2 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


  14. Low-density lipoprotein cholesterol (LDL) [ Time Frame: 2 years ]
    Serum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method

  15. Total cholesterol [ Time Frame: 2 years ]
    Serum total cholesterol concentration measured using colorimetric method

  16. Plasma metabolome [ Time Frame: 2 years ]
    plasma metabolites concentrations measured using untargeted metabolomics

  17. Skeletal muscle transcriptome [ Time Frame: 2 years ]
    skeletal muscle gene and smallRNA expressions measured using untargeted transcriptomics

  18. Skeletal muscle metabolome [ Time Frame: 2 years ]
    skeletal muscle metabolites concentrations measured using untargeted metabolomics

  19. Plasma microRNAs [ Time Frame: 2 years ]
    Expression of circulating smallRNA


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04657367


Contacts
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Contact: Lukasz Szczerbinski, MD, PhD +48858318150 lukasz.szczerbinski@umb.edu.pl

Locations
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Poland
Clinical Research Centre, Medical University of Bialystok Recruiting
Bialystok, Podlaskie, Poland, 15-276
Contact: Lukasz Szczerbinski, MD, PhD    +48 85 831 81 50    lukasz.szczerbinski@umb.edu.pl   
Principal Investigator: Adam Kretowski, Prof., MD, PhD         
Principal Investigator: Lukasz Szczerbinski, MD, PhD         
Sponsors and Collaborators
Medical University of Bialystok
More Information
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Responsible Party: Medical University of Bialystok
ClinicalTrials.gov Identifier: NCT04657367    
Other Study ID Numbers: R-I- 002/436/2019
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Bialystok:
diabetes registry
prediabetes registry
Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Hyperglycemia