NCT06351176

Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes

Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes : DenSiFy (Diabetes Spine Fractures) Cohort

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 163 (estimated)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes Mellitus, Type 1
• Bone Health
• Bone Loss
• Bone Diseases, Metabolic
• Hyperglycaemia Due to Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Clinical tests	The investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant.
DIAGNOSTIC_TEST	Biochemical tests	The investigators perform blood and urine tests in every participant.
DIAGNOSTIC_TEST	DXA scan with TBS and VFA	The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) including trabecular bone score (TBS) and Vertebral Fracture Assessment (VFA) in every participant.
DIAGNOSTIC_TEST	AGEReader	The investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine in every participant.

Timeline

• Start date: 2023-07-04
• Primary completion: 2024-12-22
• Completion: 2025-08-29
• First posted: 2024-04-08
• Last updated: 2024-04-08

Locations

2 sites across 1 country: Canada