Polish Registry of Diabetes (PolReD)

NCT04657367 | Recruiting

• 1 other identifier: R-I- 002/436/2019
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes; Obesity; PreDiabetes; Dysglycemia

Keywords

diabetes registry; prediabetes registry

Outcome Measures

Primary Outcomes (19)

• 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

Study Arms (3)

Diabetes

Patients with diagnosed diabetes

Other: Observational study - registry

Prediabetes

Patients with diagnosed prediabetes defined as impaired fasting glucose and/or impaired glucose tolerance

Other: Observational study - registry

Normoglycemia

Patients with normoglycemia, based on the OGTT - normal fasting glucose and normal glucose tolerance

Other: Observational study - registry

Interventions

Observational study - registry OTHER

Observational study - registry

Diabetes; Normoglycemia; Prediabetes

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Bialystok: lead

Study Sites (1)

Clinical Research Centre, Medical University of Bialystok

Bialystok, Podlaskie Voivodeship, 15-276, Poland

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Obesity; Prediabetic State

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lukasz Szczerbinski, MD, PhD

CONTACT

+48858318150; lukasz.szczerbinski@umb.edu.pl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: February 3, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 26, 2025

Record last verified: 2024-11

Locations

PL (1)