Dyslipidemias, Obesity, Overweight, PreDiabetes, Type 2 Diabetes
Conditions
Keywords
exercise intervention, type 2 diabetes prevention, type 2 diabetes treatment, prediabetes, behavioural intervention
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.
Interventions
BEHAVIORALExercise 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.
Sponsors
Medical University of Bialystok
University of Copenhagen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
35 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Weight | Three months | Total body weight measured using standardized scale |
| HOMA-IR | Three months | Homeostatic model assessment for insulin resistance |
| HOMA-beta | Three months | Homeostatic model assessment of beta cell function |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Poland
Outcome results
None listed