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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Type 2 Diabetes
• Intervention / Treatment: Behavioral: 8 weeks individualized training program

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Nimes
    • Nîmes, Nimes, France, 30029
      • Service d'Explorations et de Médecine Vasculaire University Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Study Population; non-diabetic obese subjects and type 2 diabetic subjects Intervention: 8 weeks individualized training program	Behavioral: 8 weeks individualized training program; no drugs added

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Peripherical vascular function at rest and during exercise	before and after training
cardiac function at rest and during exercise	before and after training (8 weeks)

Secondary Outcome Measures

Outcome Measure	Time Frame
metabolic profile (biological data)	before and after training (8 weeks)
body composition and BMI	before and after training (8 weeks)
VO2	before and after training (8 weeks)
substrate utilization during exercise	before and after training (8 weeks)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Antonia Pérez-Martin, MD, PhD, University Hospital Center of Nimes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): December 31, 2010
• Study Completion (Actual): December 31, 2010

Study Registration Dates

• First Submitted: December 12, 2005
• First Submitted That Met QC Criteria: December 12, 2005
• First Posted (Estimated): December 13, 2005

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: body composition; vascular function; ultrasonography; cardiac function; individualized training
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PHRC-I/2004/APM; DGS2005/0097 (Other Identifier: CHU Nîmes, PHRC-I competition number)