Polish Registry of Diabetes - PL: Polski Rejestr Diabetologiczny (PolReD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Homeostatic model assessment for insulin resistance (HOMA-IR)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Homeostatic model assessment for insulin resistance (HOMA-IR)
时间窗: every 5 years
Homeostatic model assessment for insulin resistance
HbA1c
时间窗: every 5 years
Haemoglobin A1c measured by the high-performance liquid chromatography (HPLC) method
2-hour glucose
时间窗: 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
Fat mass
时间窗: every 5 years
Total body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Fasting glucose
时间窗: every 5 years
Fasting glucose concentration measured in plasma using the colorimetric method
Low-density lipoprotein cholesterol (LDL)
时间窗: every 5 years
Serum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method
Plasma metabolome
时间窗: every 5 years
plasma metabolites concentrations measured using untargeted metabolomics
Skeletal muscle metabolome
时间窗: every 5 years
skeletal muscle metabolites concentrations measured using untargeted metabolomics
Fasting insulin
时间窗: every 5 years
Fasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)
Total cholesterol
时间窗: every 5 years
Serum total cholesterol concentration measured using colorimetric method
Visceral Adipose Tissue mass
时间窗: every 5 years
Visceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Weight
时间窗: every 5 years
Total body weight measured using standardized scale
Lean body mass
时间窗: every 5 years
Total lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Homeostatic model assessment of beta cell function (HOMA-beta)
时间窗: every 5 years
Homeostatic model assessment of beta cell function
VO2max
时间窗: every 5 years
Maximal oxygen consumption measured during cardio-pulmonary exercise test
Triglycerides (TG)
时间窗: every 5 years
Serum triglycerides concentration measured using colorimetric method
High-density lipoprotein cholesterol (HDL)
时间窗: 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
Skeletal muscle transcriptome
时间窗: every 5 years
skeletal muscle gene and smallRNA expressions measured using untargeted transcriptomics
Plasma microRNAs
时间窗: every 5 years
Expression of circulating smallRNA
次要结局
未报告次要终点