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

NCT ID: NCT00264589

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2010-12-31

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.

Conditions

Type 2 Diabetes; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Study Population

non-diabetic obese subjects and type 2 diabetic subjects

Intervention: 8 weeks individualized training program

Group Type: OTHER

8 weeks individualized training program

Intervention Type: BEHAVIORAL

no drugs added

Interventions

8 weeks individualized training program

no drugs added

Intervention Type: BEHAVIORAL

Eligibility 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 %

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonia Pérez-Martin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Center of Nimes

Locations

Service d'Explorations et de Médecine Vasculaire University Hospital Center

Nîmes, Nimes, France

Countries

France

References

Vinet A, Karpoff L, Walther G, Startun A, Obert P, Goret L, Dauzat M, Perez-Martin A. Vascular reactivity at rest and during exercise in middle-aged obese men: effects of short-term, low-intensity, exercise training. Int J Obes (Lond). 2011 Jun;35(6):820-8. doi: 10.1038/ijo.2010.206. Epub 2010 Sep 28.

Reference Type: RESULT

PMID: 20877288 (View on PubMed)

Other Identifiers

DGS2005/0097

Identifier Type: OTHER

Identifier Source: secondary_id

PHRC-I/2004/APM

Identifier Type: -

Identifier Source: org_study_id