Polish Registry of Diabetes (PolReD) (PolReD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Diabetes; PreDiabetes; Dysglycemia
• Intervention / Treatment: Other: Observational study - registry

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Lukasz Szczerbinski, MD, PhD; Phone Number: +48858318150; Email: lukasz.szczerbinski@umb.edu.pl

Study Locations

• Poland
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-276
      • Recruiting
      • Clinical Research Centre, Medical University of Bialystok
      • Contact: Lukasz Szczerbinski, MD, PhD; Phone Number: +48 85 831 81 50; Email: lukasz.szczerbinski@umb.edu.pl
      • Principal Investigator: Adam Kretowski, Prof., MD, PhD
      • Principal Investigator: Lukasz Szczerbinski, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Bialystok

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (Actual): December 8, 2020

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: diabetes registry; prediabetes registry
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: R-I- 002/436/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No