Abnormal Structure and Bone Density in Diabetes

August 27, 2021 updated by: Institut National de la Santé Et de la Recherche Médicale, France

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The population studies on subjects with type 1 and 2 diabetes have revealed a fracture risk multiplied by 4 to 12, especially at the shoulder, hip, ankle and foot, compared to a population of non-diabetic subjects matched for age and sex.

If osteopenia (decreased bone mineral density) is consistently associated with fracture risk in diabetic patients with type 1 diabetes type 2 often have a bone mineral density comparable or superior to non diabetes subjects.

The various causes mentioned in this alteration of the quantity and bone quality in the context of chronic hyperglycemia is a disturbance of the interaction between osteoblasts (cells forming bone) and osteoclasts (cells that resorb bone), partly mediated by the system RANK / RANK-L / osteoprotegerin with decreased bone formation and increased osteolyses. The peripherical neuropathy, the glycation proteins (modifications of proteins by addition of glucose) and the receptor of glycation proteins are directly involved.

At the foot, these changes in the bones (osteopenia and decreased bone quality) are responsible for deformations observed in some diabetic subjects, resulting in the formation of "Charcot foot" and the risk of sores and amputation as a major disability cause. Few studies have examined the abnormalities that we could find at the foot of the diabetic patients before the development of deformities observed in the Charcot foot. One study looked at bone mineral density measured by ultrasound at the Charcot foot and the contralateral foot in subjects with type 1 or type 2 compared to subjects with no diabetic Charcot foot. The authors found a decrease in bone density measured by ultrasound at the Charcot foot compared with the contralateral foot in subjects with type 1 and type 2. Bone density at the contralateral foot was reduced compared with control subjects with diabetes only in subjects with type 1 diabetes but not in patients with type 2 diabetes. The link with the peripheral neuropathy is not clear. A second study in women with type 1 diabetes in premenopausal also found a decrease in bone density at the calcaneus measured by ultrasound compared with women without diabetes. None of these studies focused on the local structure of the bone. Yet we may suspect that hyperglycemia, including glycation of proteins may cause structural changes in the bone of diabetic subjects. Previously, it was difficult to understand the structure of bone by non-invasive, the MicroScanner developed by the Scanco company can measure bone density and trabecular architecture of the wrist and ankle with a discrimination of 42 microns . He does a minimal radiation (3 microsV) and allows a resolution of 80 microns. It has already been used in osteopenic women and showed significant differences in terms of bone architecture between women with fracture and those who do not.

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 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
79

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75004
        • Hotel Dieu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
18 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
correlation involving bone and extension of neuropathy Assessment criteria associated with biological abnormalities qualitative and quantitative bone in diabetic subjects
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Christian Boitard, MD, Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C08-25
  • 2008-A00937-48 (Registry Identifier: IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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