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Study of Abnormal Structure and Bone Density at the Feet of Diabetic Patients

This study is currently Recruiting

March 2010 By Institut National de la Sant? Et de la Recherche M?dicale, France

First Recieved on March 10, 2010

Last Updated on March 26, 2010

Sponsor: Institut National de la Sant? Et de la Recherche M?dicale, France
Collaborators:
Information provided by: Institut National de la Sant? Et de la Recherche M?dicale, France
Identifier: NCT01094899

Purpose

Assumptions and Objectives: The working hypotheses are: 1 - subjects with type 1 diabetes and / or type 2, compared to subjects without diabetes are at risk for osteopenia and / or abnormal bone structure the foot (calcaneus and ankle) can lead to bone deformities, fractures and final stage of Charcot foot. These anomalies are favored by the presence of peripheral neuropathy and plasma levels of advanced glycation end products higher than in diabetic subjects without bone abnormalities. The objectives of this research are to evaluate these anomalies quantitative and qualitative bone in the foot (calcaneus and ankle) through the use of MicroScanner. In parallel a whole body bone mineral density (BMD) and calcaneal ultrasound will be performed to measure bone mineral density as realized in clinical practice in a defined population of patients with type 1 or type 2. These bone abnormalities will be correlated with the presence of peripheral neuropathy and the rate of advanced glycation end products of proteins and reference to parameters of chronic inflammation and oxidative stress to better understand the pathophysiology and target a population at risk. The importance of this study is paramount in the management of diabetic foot. Indeed for the moment we are dealing primarily the consequences of diabetes impact bone when bone deformities have appeared with their attendant disability and the risk of recurrent infections in areas of friction in this fragile environment. The ultimate goal is to target people with diabetes have abnormal bone subclinical and take care to avoid changes to bone deformities and find ways to treat them.

Study Type: Interventional
Study Design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Eligibility

Ages Eligible for Study:30 Years
Genders Eligible for Study:Male
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - Adult with type 1 or 2 diabetes with or without neuropathy Exclusion Criteria: - Pathology affecting bone metabolism: - abnormalities of phosphate metabolism proved biologically hepatic, - chronic alcoholism - renal insufficiency (creatinine clearance < 60 ml / min) - hyperthyroidism, - intoxication active smoking, - occlusive arteritis of lower limbs (IPS > IPS 1.2 or < 0.9) - Treatment affecting bone metabolism (corticosteroids or glitazones for over 3 months in the year or bisphosphonates within 6 months) - Known HIV positive serology - Progressive, inflammatory disease (rheumatoid arthritis, ankylosing spondylitis, bowel inflammatory)

Investigators

  • Investigator: Christian Boitard, MD - Study Director - Institut National de la Sant? Et de la Recherche M?dicale, France

Locations

  • Hotel Dieu

    Paris, 75004 France

Conditions related to this trial:

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