Exercise Training and Cardiovascular Function in Obesity and in Type 2 Diabetes

Study Overview
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Brief Summary
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Obesity and diabetes increase cardiovascular risk by complex and incompletely known mechanisms. The aims of this study are : to compare cardiac and vascular functions at rest and during exercise in 4 groups of age-matched men, without cardiovascular diseases but exhibiting increasing cardiovascular risk: trained and untrained healthy volunteers, obese and type 2 diabetic subjects to test the effects of a 8-weeks long individualized training program on these functions in obese subjects and in diabetics patients.

Detailed Description
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Obesity, especially in its truncal distribution, and type 2 diabetes, increase cardiovascular risk. Mechanisms underlaying both early preclinical, and clinical cardiovascular complications are complex and still incompletely clarified. However, relationship between central, i.e. cardiac, and peripheral, i.e. vascular dysfunctions remains unclear, as well as their respective role in reduced exercise tolerance in these populations. Moreover, exercise training can improve both metabolic status and cardiovascular risk, and thus, has proven useful in management and prevention of chronic metabolic diseases. Nevertheless, respective effects of training on cardiac and vascular functions, and on their interaction at rest, but also during exercise, need to be clarified. Therefore, the aims of this study are : to compare cardiac and vascular functions at rest and during a local maximal leg exercise in 4 groups of age-matched men, without cardiovascular diseases but exhibiting increasing cardiovascular risk: trained and untrained healthy volunteers, obese and type 2 diabetic subjects to test the effects of a 8-weeks long individualized training program on these functions in obese subjects and in diabetics patients.

Official Title
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Effects of an Individualized Training Program on Cardiovascular Function at Rest and During Exercise in Obese and in Type 2 Diabetic Subjects

Conditions
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Type 2 Diabetes, Obesity

Intervention / Treatment
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* Behavioral: 8 weeks individualized training program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-diabetic obese subjects and type 2 diabetic subjects Exclusion Criteria: smoking known peripheral artery insufficiency heart failure uncontrolled hypertension thyroid disease insulin dependent diabetes for diabetics subjects : HbA1c > 10 %

Ages Eligible for Study
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Minimum Age: 18 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

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study Population<br>non-diabetic obese subjects and type 2 diabetic subjects Intervention: 8 weeks individualized training program | Behavioral: 8 weeks individualized training program<br>* no drugs added<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripherical vascular function at rest and during exercise |  | before and after training | 
| cardiac function at rest and during exercise |  | before and after training (8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metabolic profile (biological data) |  | before and after training (8 weeks) | 
| body composition and BMI |  | before and after training (8 weeks) | 
| VO2 |  | before and after training (8 weeks) | 
| substrate utilization during exercise |  | before and after training (8 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vascular function, cardiac function, individualized training, ultrasonography, body composition