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Abnormal Structure and Bone Density in Diabetes

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ClinicalTrials.gov Identifier: NCT01094899
Recruitment Status : Unknown
Verified January 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Recruiting
First Posted : March 29, 2010
Last Update Posted : January 31, 2012
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief 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.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Type 2 Diabetes Radiation: Radiography Other: Urine and Blood sampling Other: Echography Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of Abnormal Structure and Bone Density at the Feet of Diabetic Patients
Study Start Date : March 2010
Actual Primary Completion Date : September 2011
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Type 1 Diabetics without Neuropathy
Adult male with type 1 diabetes and without peripherical neuropathy
Radiation: Radiography
Radiography, microscanner, osteodensitometry

Other: Urine and Blood sampling
mainly dosage of bones metabolism

Other: Echography
body bones echography

Experimental: Type 2 Diabetics without Neuropathy
Adult male with type 2 diabetes and without peripherical neuropathy
Radiation: Radiography
Radiography, microscanner, osteodensitometry

Other: Urine and Blood sampling
mainly dosage of bones metabolism

Other: Echography
body bones echography

Experimental: Type 1 Diabetics with Neuropathy
Adult male with type 1 diabetes and with peripherical neuropathy
Radiation: Radiography
Radiography, microscanner, osteodensitometry

Other: Urine and Blood sampling
mainly dosage of bones metabolism

Other: Echography
body bones echography

Experimental: Type 2 Diabetics with Neuropathy
Adult male with type 1 diabetes and with peripherical neuropathy
Radiation: Radiography
Radiography, microscanner, osteodensitometry

Other: Urine and Blood sampling
mainly dosage of bones metabolism

Other: Echography
body bones echography




Primary Outcome Measures :
  1. evaluate the MicroScanner, alterations quantitative and qualitative bone in the foot in patients with type 1 diabetes 2 with or without neuropathy [ Time Frame: 18 month ]

Secondary Outcome Measures :
  1. correlation involving bone and extension of neuropathy Assessment criteria associated with biological abnormalities qualitative and quantitative bone in diabetic subjects [ Time Frame: 18 months ]


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094899


Contacts
Contact: Boitard Christian, MD 01.42.34.80.54 christian.boitard@htd.aphp.fr

Locations
France
Hotel Dieu Recruiting
Paris, France, 75004
Contact: gonfroy-leymarie    06.23.17.49.25    celine.gonfroy@mail.com   
Sub-Investigator: gonfroy-leymarie céline         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Study Director: Christian Boitard, MD Institut National de la Santé Et de la Recherche Médicale, France

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01094899     History of Changes
Other Study ID Numbers: C08-25
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
diabetes
osteopenia
neuropathy
foot
AGE

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases