Type 2 Diabetes and Bone Microarchitecture
1 other identifier
observational
582
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedFirst Submitted
Initial submission to the registry
July 23, 2020
CompletedFirst Posted
Study publicly available on registry
February 21, 2021
CompletedFebruary 21, 2021
July 1, 2020
6 months
July 23, 2020
February 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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)
Study Arms (2)
Patients with Type 2 diabetes
Subjects from 3 cohorts (QUALYOR, OFELY, STRAMBO) presenting type 2 diabetes
Control subjects without Type 2 diabetes
Controls patients from 3 cohorts (QUALYOR, OFELY, STRAMBO) without type 2 diabetes
Interventions
Eligibility Criteria
Men and women included in the 3 cohorts (QUALYOR, OFELY, STRAMBO)
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
INSERM U1033, pavillon F, Hôpital E. Herriot. 5, place d'Arsonval
Lyon, 69437, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2020
First Posted
February 21, 2021
Study Start
January 1, 2020
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
February 21, 2021
Record last verified: 2020-07