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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Centre Hospitalier Universitaire de Nīmes

ClinicalTrials.gov Identifier:

NCT00264589

First received: December 12, 2005

Last updated: March 23, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 12, 2005

Last Updated Date

March 23, 2013

Start Date ^ICMJE

December 2005

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Peripherical vascular function at rest and during exercise [ Time Frame: before and after training ] [ Designated as safety issue: No ]
cardiac function at rest and during exercise [ Time Frame: before and after training (8 weeks) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Peripherical vascular function at rest and during exercise
cardiac function at rest and during exercise

Change History

Complete list of historical versions of study NCT00264589 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

metabolic profile (biological data) [ Time Frame: before and after training (8 weeks) ] [ Designated as safety issue: No ]
body composition and BMI [ Time Frame: before and after training (8 weeks) ] [ Designated as safety issue: No ]
VO2 [ Time Frame: before and after training (8 weeks) ] [ Designated as safety issue: No ]
substrate utilization during exercise [ Time Frame: before and after training (8 weeks) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

metabolic profile (biological data)
body composition and BMI
VO2
substrate utilization during exercise

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Type 2 Diabetes
Obesity

Intervention ^ICMJE

Behavioral: 8 weeks individualized training program

no drugs added

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2011

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 %

Gender

Male

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00264589

Other Study ID Numbers ^ICMJE

PHRC-I/2004/APM, PHRC R15-1

Has Data Monitoring Committee

Responsible Party

Centre Hospitalier Universitaire de Nīmes

Study Sponsor ^ICMJE

Centre Hospitalier Universitaire de Nīmes

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Antonia Pérez-Martin, MD, PhD

University Hospital Center of Nimes

Information Provided By

Centre Hospitalier Universitaire de Nīmes

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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