Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10000 participants
OBSERVATIONAL
2020-02-03
2030-12-31
Brief Summary
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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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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Diabetes
Patients with diagnosed diabetes
Observational study - registry
Observational study - registry
Prediabetes
Patients with diagnosed prediabetes defined as impaired fasting glucose and/or impaired glucose tolerance
Observational study - registry
Observational study - registry
Normoglycemia
Patients with normoglycemia, based on the OGTT - normal fasting glucose and normal glucose tolerance
Observational study - registry
Observational study - registry
Interventions
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Observational study - registry
Observational study - registry
Eligibility Criteria
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Inclusion Criteria
* patients with diagnosed prediabetes (IFG and/or IGT) - prediabetes group
* patients with normoglycemia (NFG and NGT) - normoglycemia group
* informed consent
Exclusion Criteria
* 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
ALL
Yes
Sponsors
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Medical University of Bialystok
OTHER
Responsible Party
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Locations
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Clinical Research Centre, Medical University of Bialystok
Bialystok, Podlaskie Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R-I- 002/436/2019
Identifier Type: -
Identifier Source: org_study_id
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