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Completed

NCT Number: NCT00264589

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Service d'Explorations et de Médecine Vasculaire University Hospital Center

Nîmes, Nimes, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 %

Treatment and study plan

8 weeks individualized training program

Behavioral

no drugs added

Primary outcomes

  1. Peripherical vascular function at rest and during exercise

    Time frame: before and after training

  2. cardiac function at rest and during exercise

    Time frame: before and after training (8 weeks)

Secondary outcomes

  1. metabolic profile (biological data)

    Time frame: before and after training (8 weeks)

  2. body composition and BMI

    Time frame: before and after training (8 weeks)

  3. VO2

    Time frame: before and after training (8 weeks)

  4. substrate utilization during exercise

    Time frame: before and after training (8 weeks)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Dec 13, 2005
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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