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

Centre Hospitalier Universitaire de Nīmes

Status and phase: Completed; Phase 4

Conditions: Obesity; Type 2 Diabetes

Treatments: Behavioral: 8 weeks individualized training program

Study type: Interventional

Funder types: Other

Identifiers

NCT00264589

DGS2005/0097 (Other Identifier)

PHRC-I/2004/APM

Details and patient eligibility

About

Obesity and diabetes increase cardiovascular risk by complex and incompletely known mechanisms. The aims of this study are :

1. 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
2. to test the effects of a 8-weeks long individualized training program on these functions in obese subjects and in diabetics patients.

Full description

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 :

1. 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
2. to test the effects of a 8-weeks long individualized training program on these functions in obese subjects and in diabetics patients.

Enrollment: 59 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 %

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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59 participants in 1 patient group

Study Population

Other group

Description:

non-diabetic obese subjects and type 2 diabetic subjects Intervention: 8 weeks individualized training program

Treatment:

Behavioral: 8 weeks individualized training program