Bialystok Exercise Study in Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Bialystok Exercise Study in Diabetes

Conditions
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Type 2 Diabetes, PreDiabetes, Overweight, Obesity, Dyslipidemias

Intervention / Treatment
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* Behavioral: Exercise intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise intervention, type 2 diabetes prevention, type 2 diabetes treatment, prediabetes, behavioural intervention