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Abnormal Structure and Bone Density in Diabetes

This study is currently recruiting participants.
Verified January 2012 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01094899
First received: March 10, 2010
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  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.


Condition Intervention
Type 1 Diabetes
Type 2 Diabetes
 Radiation: Radiography
Other: Urine and Blood sampling
Other: Echography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Study of Abnormal Structure and Bone Density at the Feet of Diabetic Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • correlation involving bone and extension of neuropathy Assessment criteria associated with biological abnormalities qualitative and quantitative bone in diabetic subjects [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: March 2010
Estimated Study Completion Date: March 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 70 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: March 10, 2010
Last Updated: January 27, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013