Bialystok Exercise Study in Diabetes
- Conditions
- Type 2 DiabetesPreDiabetesOverweightObesityDyslipidemias
- Interventions
- Behavioral: Exercise intervention
- Registration Number
- NCT04634890
- Lead Sponsor
- Medical University of Bialystok
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 300
- Age: 35-65 years old
- BMI: 25-35 kg/m2
- Male gender
- Ability of performing exercise trainings
- Sedentary lifestyle
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normoglycemia Exercise intervention Subjects with normal fasting glucose and normal glucose tolerance Prediabetes Exercise intervention Subjects with prediabetes, defined as impaired fasting glucose or/and impaired glucose tolerance Type 2 Diabetes Exercise intervention Subjects with type 2 diabetes, diagnosed within the last 3-5 years, treated with metformin only as an anti-diabetic drug
- Primary Outcome Measures
Name Time Method HOMA-beta Three months Homeostatic model assessment of beta cell function
Weight Three months Total body weight measured using standardized scale
HOMA-IR Three months Homeostatic model assessment for insulin resistance
HbA1c Three months Haemoglobin A1c measured by the high-performance liquid chromatography (HPLC) method
Fasting glucose Three months Fasting glucose concentration measured in plasma using the colorimetric method
2-hour glucose Three months Glucose concentration at 2-hour of the oral glucose tolerance test, measured in plasma using the colorimetric method
Fasting insulin Three months Fasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)
Lean body mass Three months Total lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Fat mass Three months Total body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Visceral Adipose Tissue mass Three months Visceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
VO2max Three months Maximal oxygen consumption measured during cardio-pulmonary exercise test on treadmill
Triglycerides (TG) Three months Serum triglycerides concentration measured using colorimetric method
High-density lipoprotein cholesterol (HDL) Three months Serum high-density lipoprotein cholesterol (HDL) concentration measured using colorimetric method
Low-density lipoprotein cholesterol (LDL) Three months Serum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method
Total cholesterol Three months Serum total cholesterol concentration measured using colorimetric method
- Secondary Outcome Measures
Name Time Method Plasma metabolome Three months Changes in plasma metabolites concentrations measured using untargeted metabolomics
Skeletal muscle metabolome Three months Changes in skeletal muscle metabolites concentrations measured using untargeted metabolomics
Subcutaneous adipose tissue metabolome Three months Changes in subcutaneous adipose tissue metabolites concentrations measured using untargeted metabolomics
Skeletal muscle transcriptome Three months Changes in skeletal muscle gene and smallRNA expressions measured using untargeted transcriptomics
Subcutaneous adipose tissue transcriptome Three months Changes in subcutaneous adipose tissue gene and smallRNA expressions measured using untargeted transcriptomics
Trial Locations
- Locations (1)
Clinical Research Centre, Medical University of Bialystok
🇵🇱Bialystok, Podlaskie, Poland