Polish Registry of Diabetes (PolReD)

Obesity Clinical Trial

— PolReD  

Official title:

Polish Registry of Diabetes - PL: Polski Rejestr Diabetologiczny (PolReD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04657367
• Other study ID #: R-I- 002/436/2019
• Status: Recruiting
• Start date: February 3, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: July 2023
• Source: Medical University of Bialystok
• Contact: Lukasz Szczerbinski, MD, PhD
• Phone: +48858318150
• Email: lukasz.szczerbinski[@]umb.edu.pl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Dysglycemia
• Glucose Intolerance
• Obesity
• PreDiabetes
• Prediabetic State

Intervention

Other:
• Observational study - registry
Observational study - registry

Locations

Country	Name	City	State
Poland	Clinical Research Centre, Medical University of Bialystok	Bialystok	Podlaskie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Bialystok

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Haemoglobin A1c measured by the high-performance liquid chromatography (HPLC) method	every 5 years
Primary	Fasting glucose	Fasting glucose concentration measured in plasma using the colorimetric method	every 5 years
Primary	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	every 5 years
Primary	Fasting insulin	Fasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)	every 5 years
Primary	Lean body mass	Total lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)	every 5 years
Primary	Fat mass	Total body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)	every 5 years
Primary	Visceral Adipose Tissue mass	Visceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)	every 5 years
Primary	Weight	Total body weight measured using standardized scale	every 5 years
Primary	Homeostatic model assessment for insulin resistance (HOMA-IR)	Homeostatic model assessment for insulin resistance	every 5 years
Primary	Homeostatic model assessment of beta cell function (HOMA-beta)	Homeostatic model assessment of beta cell function	every 5 years
Primary	VO2max	Maximal oxygen consumption measured during cardio-pulmonary exercise test	every 5 years
Primary	Triglycerides (TG)	Serum triglycerides concentration measured using colorimetric method	every 5 years
Primary	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	every 5 years
Primary	Low-density lipoprotein cholesterol (LDL)	Serum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method	every 5 years
Primary	Total cholesterol	Serum total cholesterol concentration measured using colorimetric method	every 5 years
Primary	Plasma metabolome	plasma metabolites concentrations measured using untargeted metabolomics	every 5 years
Primary	Skeletal muscle transcriptome	skeletal muscle gene and smallRNA expressions measured using untargeted transcriptomics	every 5 years
Primary	Skeletal muscle metabolome	skeletal muscle metabolites concentrations measured using untargeted metabolomics	every 5 years
Primary	Plasma microRNAs	Expression of circulating smallRNA	every 5 years