Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT04657367
Status:
RECRUITING
Last Update Posted:
2025-03-26
First Post:
2020-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Polish Registry of Diabetes (PolReD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D011236', 'term': 'Prediabetic State'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2020-12-01', 'studyFirstSubmitQcDate': '2020-12-01', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'every 5 years', 'description': 'Haemoglobin A1c measured by the high-performance liquid chromatography (HPLC) method'}, {'measure': 'Fasting glucose', 'timeFrame': 'every 5 years', 'description': 'Fasting glucose concentration measured in plasma using the colorimetric method'}, {'measure': '2-hour glucose', 'timeFrame': 'every 5 years', 'description': 'Glucose concentration at 2-hour of the oral glucose tolerance test, measured in plasma using the colorimetric method - only in non-diabetic subjects'}, {'measure': 'Fasting insulin', 'timeFrame': 'every 5 years', 'description': 'Fasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)'}, {'measure': 'Lean body mass', 'timeFrame': 'every 5 years', 'description': 'Total lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)'}, {'measure': 'Fat mass', 'timeFrame': 'every 5 years', 'description': 'Total body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)'}, {'measure': 'Visceral Adipose Tissue mass', 'timeFrame': 'every 5 years', 'description': 'Visceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)'}, {'measure': 'Weight', 'timeFrame': 'every 5 years', 'description': 'Total body weight measured using standardized scale'}, {'measure': 'Homeostatic model assessment for insulin resistance (HOMA-IR)', 'timeFrame': 'every 5 years', 'description': 'Homeostatic model assessment for insulin resistance'}, {'measure': 'Homeostatic model assessment of beta cell function (HOMA-beta)', 'timeFrame': 'every 5 years', 'description': 'Homeostatic model assessment of beta cell function'}, {'measure': 'VO2max', 'timeFrame': 'every 5 years', 'description': 'Maximal oxygen consumption measured during cardio-pulmonary exercise test'}, {'measure': 'Triglycerides (TG)', 'timeFrame': 'every 5 years', 'description': 'Serum triglycerides concentration measured using colorimetric method'}, {'measure': 'High-density lipoprotein cholesterol (HDL)', 'timeFrame': 'every 5 years', 'description': 'Serum high-density lipoprotein cholesterol (HDL) concentration measured using colorimetric method Serum high-density lipoprotein cholesterol (HDL) concentration measured using colorimetric method\n\nSerum high-density lipoprotein cholesterol (HDL) concentration measured using colorimetric meth'}, {'measure': 'Low-density lipoprotein cholesterol (LDL)', 'timeFrame': 'every 5 years', 'description': 'Serum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method'}, {'measure': 'Total cholesterol', 'timeFrame': 'every 5 years', 'description': 'Serum total cholesterol concentration measured using colorimetric method'}, {'measure': 'Plasma metabolome', 'timeFrame': 'every 5 years', 'description': 'plasma metabolites concentrations measured using untargeted metabolomics'}, {'measure': 'Skeletal muscle transcriptome', 'timeFrame': 'every 5 years', 'description': 'skeletal muscle gene and smallRNA expressions measured using untargeted transcriptomics'}, {'measure': 'Skeletal muscle metabolome', 'timeFrame': 'every 5 years', 'description': 'skeletal muscle metabolites concentrations measured using untargeted metabolomics'}, {'measure': 'Plasma microRNAs', 'timeFrame': 'every 5 years', 'description': 'Expression of circulating smallRNA'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes registry', 'prediabetes registry'], 'conditions': ['Diabetes', 'Obesity', 'PreDiabetes', 'Dysglycemia']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nThe 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.\n\nAs 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).\n\nIn 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).\n\nAs 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with diagnosed diabetes (according to the American Diabetes Association criteria) - diabetes group\n* patients with diagnosed prediabetes (IFG and/or IGT) - prediabetes group\n* patients with normoglycemia (NFG and NGT) - normoglycemia group\n* informed consent\n\nExclusion Criteria:\n\n* drug addiction\n* severe psychiatric disorders\n* patients with gestational diabetes mellitus\n* patients unable to give informed consent, legally incompetent or incapable to comply with the study terms and conditions'}, 'identificationModule': {'nctId': 'NCT04657367', 'acronym': 'PolReD', 'briefTitle': 'Polish Registry of Diabetes (PolReD)', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Bialystok'}, 'officialTitle': 'Polish Registry of Diabetes - PL: Polski Rejestr Diabetologiczny (PolReD)', 'orgStudyIdInfo': {'id': 'R-I- 002/436/2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetes', 'description': 'Patients with diagnosed diabetes', 'interventionNames': ['Other: Observational study - registry']}, {'label': 'Prediabetes', 'description': 'Patients with diagnosed prediabetes defined as impaired fasting glucose and/or impaired glucose tolerance', 'interventionNames': ['Other: Observational study - registry']}, {'label': 'Normoglycemia', 'description': 'Patients with normoglycemia, based on the OGTT - normal fasting glucose and normal glucose tolerance', 'interventionNames': ['Other: Observational study - registry']}], 'interventions': [{'name': 'Observational study - registry', 'type': 'OTHER', 'description': 'Observational study - registry', 'armGroupLabels': ['Diabetes', 'Normoglycemia', 'Prediabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15-276', 'city': 'Bialystok', 'state': 'Podlaskie Voivodeship', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Lukasz Szczerbinski, MD, PhD', 'role': 'CONTACT', 'email': 'lukasz.szczerbinski@umb.edu.pl', 'phone': '+48 85 831 81 50'}, {'name': 'Adam Kretowski, Prof., MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lukasz Szczerbinski, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinical Research Centre, Medical University of Bialystok', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}], 'centralContacts': [{'name': 'Lukasz Szczerbinski, MD, PhD', 'role': 'CONTACT', 'email': 'lukasz.szczerbinski@umb.edu.pl', 'phone': '+48858318150'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Bialystok', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}