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

Phase 4

Completed

• Conditions: Type 2 Diabetes; Obesity
• Interventions: Behavioral: 8 weeks individualized training program

• Registration Number: NCT00264589
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-12
• Study First Submitted QC: 2005-12-12
• Study First Posted: 2005-12-13
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 59

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 %

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Population	8 weeks individualized training program	non-diabetic obese subjects and type 2 diabetic subjects Intervention: 8 weeks individualized training program

Primary Outcome Measures

Name	Time	Method
cardiac function at rest and during exercise	before and after training (8 weeks)
Peripherical vascular function at rest and during exercise	before and after training

Secondary Outcome Measures

Name	Time	Method
substrate utilization during exercise	before and after training (8 weeks)
body composition and BMI	before and after training (8 weeks)
VO2	before and after training (8 weeks)
metabolic profile (biological data)	before and after training (8 weeks)

Trial Locations

Locations (1)

Service d'Explorations et de Médecine Vasculaire University Hospital Center; 🇫🇷 Nimes, France