Clinical Tests
Diagnostic TestThe investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant.
NCT Number: NCT04064437
Background : Type 1 diabetes is associated with an increased risk of fractures. The mechanisms accounting for this bone fragility are not yet fully understood. The lower bone mineral density (BMD) observed in individuals with type 1 diabetes cannot solely explain the higher fracture incidence. Bone microarchitecture defects significantly contribute to bone fragility. Few studies assessed spine fractures in type 1 diabetes.
This cross-sectional multicenter case-control study aims (1) to evaluate the prevalence of asymptomatic vertebral fractures in individuals with type 1 diabetes in comparison to age- and sex-matched healthy controls; (2) to compare individuals with diabetes with vertebral fractures and those without vertebral fracture using clinical, biochemical and radiological parameters.
Looking for future studies?
Notify Me20 year and older
All sexes
Observational
Institut de recherches cliniques de Montréal (IRCM), Montreal, Quebec, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Individuals with type 1 diabetes
Inclusion criteria
Exclusion criteria
Healthy controls
Inclusion criteria
Exclusion criteria
The investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant.
The investigators perform blood and urine tests in every participant.
The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) in every participant.
The investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine in every participant.
Time frame: Baseline
Vertebral Fracture Assessment (VFA) software of dual-energy X-ray absorptiometry (DXA scan) is used to identify vertebral fractures. If there is evidence of a vertebral fracture on VFA, a lateral and anteroposterior spine X-ray will be obtained to confirm the VFA results.
Time frame: Baseline
Measured by DXA scan
Time frame: Baseline
Measured by DXA scan
Time frame: Baseline
Measured by DXA scan
Time frame: Baseline
Measured by DXA scan
Time frame: Baseline
Measured by DXA scan
Time frame: Baseline
Measured by DXA scan
Time frame: Baseline
Measured by DXA scan
Time frame: Baseline
Measured by DXA scan
Time frame: Baseline
Measured by DXA scan
Time frame: Baseline
Measured by DXA scan
Time frame: Baseline
Measured by DXA scan
Time frame: Baseline
Measured by DXA scan
Time frame: Baseline
Body composition measured by DXA scan
Time frame: Baseline
Body composition measured by DXA scan
Time frame: Baseline
Measured by AGE Reader
Time frame: Baseline
Bone turnover marker (serum)
Time frame: Baseline
Bone turnover marker (serum)
Time frame: Baseline
Bone turnover marker (serum)
Time frame: Baseline
Diabetes control marker
Time frame: Baseline
Blood level measurement
Time frame: Baseline
Blood level measurement
Time frame: Baseline
Blood level measurement
Time frame: Baseline
Blood level measurement
Time frame: Baseline
Blood level measurement
Time frame: Baseline
Blood level measurement
Time frame: Baseline
Blood level measurement
Time frame: Baseline
Blood level measurement
Time frame: Baseline
Blood level measurement
Time frame: Baseline
Blood level measurement
Time frame: Baseline
Blood level measurement
Time frame: Baseline
Blood level measurement
Time frame: Baseline
Blood level measurement
Time frame: Baseline
Blood level measurement
Time frame: Baseline
Blood level measurement
Time frame: Baseline
Urine microalbuminuria / urine creatinine ratio measurement
CHU de Quebec-Universite Laval
Other
Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes (Diabetes Spine Fractures, DenSiFy)
Acronym: DenSiFy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03869281
Autoimmune Diseases, Diabetes Mellitus
Milan, Please Select, Italy
View Trial DetailsNCT06236256
Autoimmune Diseases, Diabetes Mellitus
Ramat Gan, Israel
View Trial DetailsNCT07711275
Autoimmune Diseases, Diabetes Mellitus
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT03938324
Anemia, Anemia, Hemolytic
Durham, North Carolina, United States
View Trial Details