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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264589
• Other study ID #: PHRC-I/2004/APM
• Secondary ID: PHRC R15-1
• Status: Completed
• Phase: Phase 4
• First received: December 12, 2005
• Last updated: March 26, 2015
• Start date: December 2005
• Est. completion date: November 2011

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes

Intervention

Behavioral:
• 8 weeks individualized training program
no drugs added

Locations

Country	Name	City	State
France	Service d'Explorations et de Médecine Vasculaire University Hospital Center	Nimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripherical vascular function at rest and during exercise		before and after training	No
Primary	cardiac function at rest and during exercise		before and after training (8 weeks)	No
Secondary	metabolic profile (biological data)		before and after training (8 weeks)	No
Secondary	body composition and BMI		before and after training (8 weeks)	No
Secondary	VO2		before and after training (8 weeks)	No
Secondary	substrate utilization during exercise		before and after training (8 weeks)	No