Bialystok Exercise Study in Diabetes (BESD)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Dyslipidemias; PreDiabetes; Type 2 Diabetes
• Intervention / Treatment: Behavioral: Exercise intervention

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-276
      • Clinical Research Centre, Medical University of Bialystok

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Type 2 Diabetes; Subjects with type 2 diabetes, diagnosed within the last 3-5 years, treated with metformin only as an anti-diabetic drug	Behavioral: Exercise intervention; 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.
Other: Prediabetes; Subjects with prediabetes, defined as impaired fasting glucose or/and impaired glucose tolerance	Behavioral: Exercise intervention; 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.
Other: Normoglycemia; Subjects with normal fasting glucose and normal glucose tolerance	Behavioral: Exercise intervention; 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.

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	Three months
Fasting glucose	Fasting glucose concentration measured in plasma using the colorimetric method	Three months
2-hour glucose	Glucose concentration at 2-hour of the oral glucose tolerance test, measured in plasma using the colorimetric method	Three months
Fasting insulin	Fasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)	Three months
Lean body mass	Total lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)	Three months
Fat mass	Total body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)	Three months
Visceral Adipose Tissue mass	Visceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)	Three months
Weight	Total body weight measured using standardized scale	Three months
HOMA-IR	Homeostatic model assessment for insulin resistance	Three months
HOMA-beta	Homeostatic model assessment of beta cell function	Three months
VO2max	Maximal oxygen consumption measured during cardio-pulmonary exercise test on treadmill	Three months
Triglycerides (TG)	Serum triglycerides concentration measured using colorimetric method	Three months
High-density lipoprotein cholesterol (HDL)	Serum high-density lipoprotein cholesterol (HDL) concentration measured using colorimetric method	Three months
Low-density lipoprotein cholesterol (LDL)	Serum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method	Three months
Total cholesterol	Serum total cholesterol concentration measured using colorimetric method	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma metabolome	Changes in plasma metabolites concentrations measured using untargeted metabolomics	Three months
Skeletal muscle metabolome	Changes in skeletal muscle metabolites concentrations measured using untargeted metabolomics	Three months
Subcutaneous adipose tissue metabolome	Changes in subcutaneous adipose tissue metabolites concentrations measured using untargeted metabolomics	Three months
Skeletal muscle transcriptome	Changes in skeletal muscle gene and smallRNA expressions measured using untargeted transcriptomics	Three months
Subcutaneous adipose tissue transcriptome	Changes in subcutaneous adipose tissue gene and smallRNA expressions measured using untargeted transcriptomics	Three months

Collaborators and Investigators

• Sponsor: Medical University of Bialystok
• Collaborators: University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2016
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: November 12, 2020
• First Submitted That Met QC Criteria: November 12, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: prediabetes; exercise intervention; behavioural intervention; type 2 diabetes prevention; type 2 diabetes treatment
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Lipid Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Diabetes Mellitus, Type 2; Dyslipidemias; Prediabetic State
• Other Study ID Numbers: R-I- 002/469/2014

Drug and device information, study documents

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