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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
  Purpose

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.

Condition Intervention Phase
Type 2 Diabetes
Obesity
 Behavioral: 8 weeks individualized training program
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Effects of an Individualized Training Program on Cardiovascular Function at Rest and During Exercise in Obese and in Type 2 Diabetic Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 59
Study Start Date: December 2005
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: 8 weeks individualized training program
    no drugs added
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 %
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264589

Locations
France
Service d'Explorations et de Médecine Vasculaire University Hospital Center
Nimes, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Antonia Pérez-Martin, MD, PhD University Hospital Center of Nimes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT00264589     History of Changes
Other Study ID Numbers: PHRC-I/2004/APM, PHRC R15-1
Study First Received: December 12, 2005
Last Updated: March 23, 2013
Health Authority: France: Ministry of Health

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
vascular function
cardiac function
individualized training
ultrasonography
body composition

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013