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

NCT00264589 | Completed Phase 4

• 2 other identifiers: PHRC-I/2004/APMDGS2005/0097
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity and diabetes increase cardiovascular risk by complex and incompletely known mechanisms. The aims of this study are :

1. 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. 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

Keywords

vascular function; cardiac function; individualized training; ultrasonography; body composition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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)

Study Arms (1)

Study Population

OTHER

non-diabetic obese subjects and type 2 diabetic subjects Intervention: 8 weeks individualized training program

Behavioral: 8 weeks individualized training program

Interventions

8 weeks individualized training program BEHAVIORAL

no drugs added

Study Population

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-diabetic obese subjects and type 2 diabetic subjects

You may not qualify if:

• smoking
• known peripheral artery insufficiency
• heart failure
• uncontrolled hypertension
• thyroid disease
• insulin dependent diabetes
• for diabetics subjects : HbA1c \> 10 %

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Service d'Explorations et de Médecine Vasculaire University Hospital Center

Nîmes, Nimes, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 20877288 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonia Pérez-Martin, MD, PhD

  University Hospital Center of Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2005
• First Posted: December 13, 2005
• Study Start: December 1, 2005
• Primary Completion: December 31, 2010
• Study Completion: December 31, 2010
• Last Updated: November 17, 2025

Record last verified: 2015-03

Locations

FR (1)