Type 2 Diabetes and Bone Microarchitecture

February 19, 2021 updated by: Hospices Civils de Lyon

Type 2 Diabetes and Bone Microarchitecture in Men and Women: a Case-control Study

Type 2 diabetes is a major public health problem, associated with an increased risk of fractures. Diabetes even appears to be the most important predictor of low kinetic fractures in men and women, and the risk of hip fracture in type 2 diabetics is increased by 40 to 50%, with often more serious consequences (post-operative complications, longer hospital stays, increased mortality rate).

Currently, the risk of fractures is estimated by the measure of areal bone mineral density (aBMD) and T-score. However, in diabetics aBMD is not decreased, and even paradoxically increased. Indeed, aBMD is 5-10% higher in type 2 diabetic patients compared to non-diabetic subjects, which suggests that the assessment of fracture risk in these patients is underestimated. The High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) 3D bone imaging technique has a resolution close to the size of the bone trabeculae. It is used to assess volumetric bone mineral density (vBMD) and bone microarchitecture at the tibia and distal radius, and enables a better estimation of the fracture risk compared to the measurement of aBMD. Our hypothesis is that bone microarchitecture is altered in type 2 diabetic patients, explaining the increased risk of fracture in this population compared to non-diabetics.

We propose to set up a descriptive case control study, nestled in 3 cohorts of men and women (QUALYOR, OFELY and STRAMBO), to compare the bone micro-architecture measured by HR-pQCT at the level of the tibia and distal radius, in type 2 diabetics compared to non-diabetic subjects from the same cohorts.

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.

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.
Observational

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.
582

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
      • Lyon, France, 69437
        • INSERM U1033, pavillon F, Hôpital E. Herriot. 5, place d'Arsonval

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Men and women included in the 3 cohorts (QUALYOR, OFELY, STRAMBO)

Description

Inclusion Criteria:

  • Men and women included in the 3 cohorts (QUALYOR, OFELY, STRAMBO) presenting type 2 diabetes
  • Age- and sex-matched control patients from the same cohorts without type 2 diabetes ; two control were age- and sex-matched to one type 2 diabetes patient.

Exclusion Criteria:

-

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Patients with Type 2 diabetes
Subjects from 3 cohorts (QUALYOR, OFELY, STRAMBO) presenting type 2 diabetes
Other: Patients with Type 2 diabetes
No intervention
Control subjects without Type 2 diabetes
Controls patients from 3 cohorts (QUALYOR, OFELY, STRAMBO) without type 2 diabetes
Other: Placebo
Placebo comparator

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
Measure Description
Time Frame
The main outcome is the comparison of total volumetric bone mineral density (vBMD) at the tibia and distal radius, in type 2 diabetics compared to non-diabetic subjects.
Time Frame: at inclusion for Qualyor patients. (the HRpQCT measure considered in this study is realised at the first visit just after inclusion of the patient for the Qualyor patients)
The main outcome is the comparison of total volumetric bone mineral density (vBMD) measured by HR-pQCT at the tibia and distal radius, in type 2 diabetics compared to non-diabetic subjects from 3 cohorts of men and women (QUALYOR, OFELY, STRAMBO).
at inclusion for Qualyor patients. (the HRpQCT measure considered in this study is realised at the first visit just after inclusion of the patient for the Qualyor patients)

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.
Hospices Civils de Lyon

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.
January 1, 2020

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, 2020

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 1, 2020

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).
July 23, 2020

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.
February 19, 2021

First Posted (ACTUAL)

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.
February 21, 2021

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.
February 21, 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.
February 19, 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.
July 1, 2020

More Information

Terms related to this study

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.
  • Type 2 diabetes bone

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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