Abnormal Structure and Bone Density in Diabetes
NCT01094899 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79
Last updated 2021-09-01
Summary
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.
Conditions
Interventions
- RADIATION
-
Radiography
Radiography, microscanner, osteodensitometry
- OTHER
-
Urine and Blood sampling
mainly dosage of bones metabolism
- OTHER
-
Echography
body bones echography
Sponsors & Collaborators
-
Institut National de la Santé Et de la Recherche Médicale, France
lead OTHER_GOV
Principal Investigators
-
Christian Boitard, MD · Institut National de la Santé Et de la Recherche Médicale, France
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 70 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-03-10
- Primary Completion
- 2014-07-31
- Completion
- 2014-07-10
Countries
- France
Study Locations
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