Bialystok Exercise Study in Diabetes

NCT04634890 | Completed

• 1 other identifier: R-I- 002/469/2014
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes; PreDiabetes; Overweight; Obesity; Dyslipidemias

Keywords

exercise intervention; type 2 diabetes prevention; type 2 diabetes treatment; prediabetes; behavioural intervention

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (5)

• Plasma metabolome

  Three months

• Skeletal muscle metabolome

  Three months

• Subcutaneous adipose tissue metabolome

  Three months

• Skeletal muscle transcriptome

  Three months

• Subcutaneous adipose tissue transcriptome

  Three months

Study Arms (3)

Type 2 Diabetes

OTHER

Subjects with type 2 diabetes, diagnosed within the last 3-5 years, treated with metformin only as an anti-diabetic drug

Behavioral: Exercise intervention

Prediabetes

OTHER

Subjects with prediabetes, defined as impaired fasting glucose or/and impaired glucose tolerance

Behavioral: Exercise intervention

Normoglycemia

OTHER

Subjects with normal fasting glucose and normal glucose tolerance

Behavioral: Exercise intervention

Interventions

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.

Normoglycemia; Prediabetes; Type 2 Diabetes

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Bialystok: lead
• University of Copenhagen: collaborator

Study Sites (1)

Clinical Research Centre, Medical University of Bialystok

Bialystok, Podlaskie Voivodeship, 15-276, Poland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State; Overweight; Obesity; Dyslipidemias

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 18, 2020
• Study Start: August 11, 2016
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: April 14, 2026

Record last verified: 2025-05

Locations

PL (1)