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NCT Number: NCT04634890

Bialystok Exercise Study in Diabetes

The "Bialystok Exercise Study in Diabetes" (BESD), is an exercise intervention study, conducted by the Department of Endocrinology, Diabetology and Internal Medicine and Clinical Research Centre of the Medical University of Bialystok. In the project, sedentary males at different stages of dysglycemia living in the city of Bialystok participate in three months of an exercise intervention consisting of supervised training sessions at a local fitness centre. The aim of the study is to assess the effectiveness of the exercise intervention in patients at different stages of dysglycemia progression, including type 2 diabetes and prediabetes and compare the response between groups.

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Signs and Symptoms

Age range

35 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Centre, Medical University of Bialystok

Bialystok, Podlaskie Voivodeship, 15-276, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 35-65 years old
  • BMI: 25-35 kg/m2
  • Male gender
  • Ability of performing exercise trainings
  • Sedentary lifestyle

Exclusion criteria

  • Smoking
  • Drug or alcohol addiction
  • Any chronic disease (exceptions: hypertension, obesity with BMI ≤ 35 kg/m2, type 2 diabetes)
  • Any chronic medications (exceptions: angiotensin-converting-enzyme inhibitors for hypertension and metformin in type 2 diabetics)
  • Highly active lifestyle
  • Medical contraindications to participate in planned exercise sessions

Treatment and study plan

Exercise Intervention

Behavioral

Supervised exercise intervention composed of mixed aerobic and strength activities, with the frequency of 3 sessions per week for 12 weeks, for a total number of trainings of 36.

Primary outcomes

  1. HbA1c

    Time frame: Three months

    Haemoglobin A1c measured by the high-performance liquid chromatography (HPLC) method

  2. Fasting glucose

    Time frame: Three months

    Fasting glucose concentration measured in plasma using the colorimetric method

  3. 2-hour glucose

    Time frame: Three months

    Glucose concentration at 2-hour of the oral glucose tolerance test, measured in plasma using the colorimetric method

  4. Fasting insulin

    Time frame: Three months

    Fasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)

  5. Lean body mass

    Time frame: Three months

    Total lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)

  6. Fat mass

    Time frame: Three months

    Total body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)

  7. Visceral Adipose Tissue mass

    Time frame: Three months

    Visceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)

  8. Weight

    Time frame: Three months

    Total body weight measured using standardized scale

  9. HOMA-IR

    Time frame: Three months

    Homeostatic model assessment for insulin resistance

  10. HOMA-beta

    Time frame: Three months

    Homeostatic model assessment of beta cell function

  11. VO2max

    Time frame: Three months

    Maximal oxygen consumption measured during cardio-pulmonary exercise test on treadmill

  12. Triglycerides (TG)

    Time frame: Three months

    Serum triglycerides concentration measured using colorimetric method

  13. High-density lipoprotein cholesterol (HDL)

    Time frame: Three months

    Serum high-density lipoprotein cholesterol (HDL) concentration measured using colorimetric method

  14. Low-density lipoprotein cholesterol (LDL)

    Time frame: Three months

    Serum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method

  15. Total cholesterol

    Time frame: Three months

    Serum total cholesterol concentration measured using colorimetric method

Secondary outcomes

  1. Plasma metabolome

    Time frame: Three months

    Changes in plasma metabolites concentrations measured using untargeted metabolomics

  2. Skeletal muscle metabolome

    Time frame: Three months

    Changes in skeletal muscle metabolites concentrations measured using untargeted metabolomics

  3. Subcutaneous adipose tissue metabolome

    Time frame: Three months

    Changes in subcutaneous adipose tissue metabolites concentrations measured using untargeted metabolomics

  4. Skeletal muscle transcriptome

    Time frame: Three months

    Changes in skeletal muscle gene and smallRNA expressions measured using untargeted transcriptomics

  5. Subcutaneous adipose tissue transcriptome

    Time frame: Three months

    Changes in subcutaneous adipose tissue gene and smallRNA expressions measured using untargeted transcriptomics

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Collaborators

  • University of Copenhagen

Registry information

Acronym: BESD

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2020
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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