Clinical trial NCT00264589: Exercise Training and Cardiovascular Function in Obesity and in Type 2 Diabetes
Official title: Effects of an Individualized Training Program on Cardiovascular Function at Rest and During Exercise in Obese and in Type 2 Diabetic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Obesity
Keywords: vascular function
cardiac function
individualized training
ultrasonography
body composition
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2005-12-13
Enrollment: 59
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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 %

Primary outcomes:
measure: Peripherical vascular function at rest and during exercise
timeFrame: before and after training
measure: cardiac function at rest and during exercise
timeFrame: before and after training (8 weeks)
Secondary outcomes:
measure: metabolic profile (biological data)
timeFrame: before and after training (8 weeks)
measure: body composition and BMI
timeFrame: before and after training (8 weeks)
measure: VO2
timeFrame: before and after training (8 weeks)
measure: substrate utilization during exercise
timeFrame: before and after training (8 weeks)
Other outcomes:
Locations:
city: Nimes
country: France
facility: Service d'Explorations et de Médecine Vasculaire University Hospital Center
Study officials:
affiliation: University Hospital Center of Nimes
name: Antonia Pérez-Martin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: