Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351176
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-08
First Post:
2024-04-02
Brief Title:
Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes
Sponsor:
CHU de Quebec-Universite Laval
Organization:
CHU de Quebec-Universite Laval
Study Overview
Official Title:
Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes DenSiFy Diabetes Spine Fractures Cohort
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DenSiFy cohort
Brief Summary:
Background Type 1 diabetes T1D is associated with an increased risk of fractures The mechanisms accounting for this bone fragility are not yet fully understood As T1D is often diagnosed in childhood or early adulthood the lower bone mineral density BMD and deteriorated bone microarchitecture observed in T1D may reflect changes in the bone that occurred before or at the time of peak bone mass achievement There is a lack of high-quality prospective studies to determine whether adults with T1D continue to lose BMD or deteriorate bone quality compared with controls Moreover while chronic hyperglycemia is a risk factor for fracture in T1D it is unknown if better glycemic control affects bone outcomes
This prospective multicenter cohort study aims 1 To compare the changes in the following outcomes over 4 years in adults with T1D and controls without diabetes of similar age sex and body-mass index distribution BMD by dual-energy X-ray absorptiometry DXA at the femoral neck hip spine and radius trabecular bone score TBS by DXA and serum biochemical markers of bone turnover BTMs 2 To evaluate whether long-term glycemic control or the presence of a microvascular complication are independent predictors of the changes in BMD and TBS in people with T1D
This prospective multicenter cohort study aims 1 To compare the changes in the following outcomes over 4 years in adults with T1D and controls without diabetes of similar age sex and body-mass index distribution BMD by dual-energy X-ray absorptiometry DXA at the femoral neck hip spine and radius trabecular bone score TBS by DXA and serum biochemical markers of bone turnover BTMs 2 To evaluate whether long-term glycemic control or the presence of a microvascular complication are independent predictors of the changes in BMD and TBS in people with T1D
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None