Mechanical Stress Effects on the Cardiovascular Adaptations of Peripheral Arterial Calcifications Among Athletes

NCT01577576 | Terminated

• 2 other identifiers: LOCAL/2012/APM-012012-A00475-38
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

The main objective of this study is to obtain data for the integrated analysis of morphological, functional and biomechanical parameters pertaining to lower limb arteries in various categories of elite athletes (without cardiovascular risk and practicing high- or low-impact aerobic activities which preferentially implicate lower limb activity) as compared to (each other and to) sedentary controls.

Conditions

Monckeberg Medial Calcific Sclerosis

Keywords

Athletes; Sedentary volunteers

Outcome Measures

Primary Outcomes (1)

• Presence / absence of intra parietal calcification of lower limb arteries

  Baseline (Day 0; transversal study)

Secondary Outcomes (48)

• Extent of intra parietal calcification of lower limb arteries

  Baseline (Day 0; transversal study)

• Inner diameter of the intima-media of the common femoral artery (mm)

  Baseline (Day 0; transversal study)

• Outer diameter of the intima-media of the common femoral artery (mm)

  Baseline (Day 0; transversal study)

• Inner diameter of the intima-media of the superficial femoral artery (mm)

  Baseline (Day 0; transversal study)

• Outer diameter of the intima-media of the superficial femoral artery (mm)

  Baseline (Day 0; transversal study)

Study Arms (3)

Upper-body athletes

This group includes swimmers, rowers or kayakers with a history of at least 10 years of intense training, and performance in regional competitions for the past five years.

Lower-body athletes

This group includes runners (marathon or trail) and cyclists with a history of at least 10 years of intense training, and performance in regional competitions for the past five years.

Sedentary volunteers

This group of healthy volunteers does not participate in athletic activity for more than two hours per week. They are matched by age and sex with the athletic groups.

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population is composed of three groups of healthy volunteers: (1) high impact lower-limb sports (marathon or trail); (2) low-impact lower-limb sports and (3) sedentary volunteers. All volunteers are between the ages of 25 and 40. The groups will be matched by age and sex. Athletic groups will be matched according to years of intensive practice and hours of training.

You may qualify if:

• The volunteer must have given his/her informed and signed consent
• The volunteer must be insured or beneficiary of a health insurance plan
• Volunteers without cardiovascular disease, glucose regulation disorders or known renal disease
• Ongoing athletic activity for the past 10 years
• Athletic activity at the regional level for the past 5 years
• Practices one of the three following sports: marathon, trail running, cycling.

You may not qualify if:

• The volunteer is participating in another study
• The volunteer is under judicial protection, under tutorship or curatorship
• The volunteer refuses to sign the consent
• It is impossible to correctly inform the volunteer
• The volunteer is pregnant, parturient, or breastfeeding
• Tobacco use
• Contraindications for the practice of physical activity (joint, heart or other)
• Intercurrent pathology
• First degree family history of cardiovascular disease
• Known dyslipidemia (including cholesterol)
• Glucose tolerance abnormalities (prediabetes or diabetes)
• Treatment with certain drugs used for treating erectile dysfunction: Sildefanil (Viagra), Tadalafil (Cialis), Vardenafil (Levitra) and yohimbine (Yohimbine Houde and Yocoral)
• More than two hours of athletic activity per week
• History of intense athletic training
• Body mass index \>= 25 kg/m\^2

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

Université d'Avignon, Faculté des Sciences

Avignon, 84000, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

A non-fasting venous blood sample is required for the following cofactors: * serum protein * serum calcium * phosphorus * PTH * Vitamin D2 and D3 Left-over serum will be stored in the Nîmes University Hospital "Sérotheque" (serum collection).

MeSH Terms

Conditions

Monckeberg Medial Calcific Sclerosis

Condition Hierarchy (Ancestors)

Vascular Calcification; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Antonia Perez Martin, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: April 16, 2012
• Study Start: September 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 30, 2015

Record last verified: 2015-11

Locations

FR (2)