Bialystok Exercise Study in Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Exercise intervention
- Conditions
- Type 2 Diabetes
- Sponsor
- Medical University of Bialystok
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Weight
- Status
- Completed
- Last Updated
- 18 days ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: 35-65 years old
- •BMI: 25-35 kg/m2
- •Male gender
- •Ability of performing exercise trainings
- •Sedentary lifestyle
Exclusion Criteria
- •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
Arms & Interventions
Type 2 Diabetes
Subjects with type 2 diabetes, diagnosed within the last 3-5 years, treated with metformin only as an anti-diabetic drug
Intervention: Exercise intervention
Prediabetes
Subjects with prediabetes, defined as impaired fasting glucose or/and impaired glucose tolerance
Intervention: Exercise intervention
Normoglycemia
Subjects with normal fasting glucose and normal glucose tolerance
Intervention: Exercise intervention
Outcomes
Primary Outcomes
Weight
Time Frame: Three months
Total body weight measured using standardized scale
HOMA-IR
Time Frame: Three months
Homeostatic model assessment for insulin resistance
HOMA-beta
Time Frame: Three months
Homeostatic model assessment of beta cell function
HbA1c
Time Frame: Three months
Haemoglobin A1c measured by the high-performance liquid chromatography (HPLC) method
Fasting glucose
Time Frame: Three months
Fasting glucose concentration measured in plasma using the colorimetric method
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
Fasting insulin
Time Frame: Three months
Fasting insulin concentration measured in plasma using the immunoradiometric assay (IRMA)
Lean body mass
Time Frame: Three months
Total lean body mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Fat mass
Time Frame: Three months
Total body fat mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
Visceral Adipose Tissue mass
Time Frame: Three months
Visceral adipose tissue mass measured using the whole-body dual-energy X-ray absorptiometry (DXA)
VO2max
Time Frame: Three months
Maximal oxygen consumption measured during cardio-pulmonary exercise test on treadmill
Triglycerides (TG)
Time Frame: Three months
Serum triglycerides concentration measured using colorimetric method
High-density lipoprotein cholesterol (HDL)
Time Frame: Three months
Serum high-density lipoprotein cholesterol (HDL) concentration measured using colorimetric method
Low-density lipoprotein cholesterol (LDL)
Time Frame: Three months
Serum low-density lipoprotein cholesterol (LDL) concentration measured using colorimetric method
Total cholesterol
Time Frame: Three months
Serum total cholesterol concentration measured using colorimetric method
Secondary Outcomes
- Skeletal muscle metabolome(Three months)
- Plasma metabolome(Three months)
- Subcutaneous adipose tissue metabolome(Three months)
- Skeletal muscle transcriptome(Three months)
- Subcutaneous adipose tissue transcriptome(Three months)