Abnormal Structure and Bone Density in Diabetes

NCT01094899 | Completed DMC

• 2 other identifiers: C08-252008-A00937-48
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Keywords

diabetes; osteopenia; neuropathy; foot; AGE

Outcome Measures

Primary Outcomes (1)

• evaluate the MicroScanner, alterations quantitative and qualitative bone in the foot in patients with type 1 diabetes 2 with or without neuropathy

  18 month

Secondary Outcomes (1)

• correlation involving bone and extension of neuropathy Assessment criteria associated with biological abnormalities qualitative and quantitative bone in diabetic subjects

  18 months

Study Arms (4)

Type 1 Diabetics without Neuropathy

EXPERIMENTAL

Adult male with type 1 diabetes and without peripherical neuropathy

Radiation: Radiography; Other: Urine and Blood sampling; Other: Echography

Type 2 Diabetics without Neuropathy

EXPERIMENTAL

Adult male with type 2 diabetes and without peripherical neuropathy

Radiation: Radiography; Other: Urine and Blood sampling; Other: Echography

Type 1 Diabetics with Neuropathy

EXPERIMENTAL

Adult male with type 1 diabetes and with peripherical neuropathy

Radiation: Radiography; Other: Urine and Blood sampling; Other: Echography

Type 2 Diabetics with Neuropathy

EXPERIMENTAL

Adult male with type 1 diabetes and with peripherical neuropathy

Radiation: Radiography; Other: Urine and Blood sampling; Other: Echography

Interventions

Radiography RADIATION

Radiography, microscanner, osteodensitometry

Type 1 Diabetics with Neuropathy; Type 1 Diabetics without Neuropathy; Type 2 Diabetics with Neuropathy; Type 2 Diabetics without Neuropathy

Urine and Blood sampling OTHER

mainly dosage of bones metabolism

Type 1 Diabetics with Neuropathy; Type 1 Diabetics without Neuropathy; Type 2 Diabetics with Neuropathy; Type 2 Diabetics without Neuropathy

Echography OTHER

body bones echography

Type 1 Diabetics with Neuropathy; Type 1 Diabetics without Neuropathy; Type 2 Diabetics with Neuropathy; Type 2 Diabetics without Neuropathy

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult with type 1 or 2 diabetes with or without neuropathy

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Hotel Dieu

Paris, 75004, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus; Bone Diseases, Metabolic

Interventions

X-Rays; Urination; Blood Specimen Collection; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Ultrasonic Waves; Sound; Radiation, Nonionizing

Study Officials

• Christian Boitard, MD

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 29, 2010
• Study Start: March 10, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 10, 2014
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

FR (1)