Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes
NCT ID: NCT04064437
Last Updated: 2024-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
192 participants
OBSERVATIONAL
2019-07-29
2021-03-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Individuals with type 1 diabetes
Clinical tests
The investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant.
Biochemical tests
The investigators perform blood and urine tests in every participant.
DXA scan
The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) in every participant.
AGE Reader
The investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine in every participant.
Healthy controls
Clinical tests
The investigators perform the following clinical tests: height, weight and waist circumference measurement in every participant.
Biochemical tests
The investigators perform blood and urine tests in every participant.
DXA scan
The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) in every participant.
AGE Reader
The investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine in every participant.
Interventions
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Clinical tests
The investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant.
Clinical tests
The investigators perform the following clinical tests: height, weight and waist circumference measurement in every participant.
Biochemical tests
The investigators perform blood and urine tests in every participant.
DXA scan
The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) in every participant.
AGE Reader
The investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine in every participant.
Eligibility Criteria
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Inclusion Criteria
* Age 20 years and older.
* Age 20 years and older.
Exclusion Criteria
* Conditions associated with bone disease (significant liver disease, intestinal malabsorption other than celiac disease, organ transplant, active cancer, rheumatoid arthritis, hyperthyroidism, hypothyroidism with abnormal thyroid-stimulating hormone (TSH), hyperparathyroidism, hypoparathyroidism, acromegaly, Cushing syndrome, adrenal insufficiency);
* Any of these medications in the past 6 months : glucocorticoids ≥ 7,5 mg prednisone/day or equivalency ≥ 3 months, aromatase inhibitors, antiandrogens, antiepileptic drugs, anticoagulants, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, thiazolidinediones;
* Past medical history of traumatic vertebral fracture;
* Inability to consent.
Healthy controls
* As above (as individuals with diabetes), and :
* Diagnosis of diabetes or prediabetes;
* Celiac disease;
* Chronic kidney disease (CrCl \< 60 mL/min);
* Any of theses medications in the past 6 months : biphosphonates, teriparatide, denosumab, calcitonin;
* Past medical history of fragility fracture.
20 Years
ALL
Yes
Sponsors
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CHU de Quebec-Universite Laval
OTHER
Responsible Party
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Claudia Gagnon
MD
Principal Investigators
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Claudia Gagnon, Dr
Role: PRINCIPAL_INVESTIGATOR
CHU de Québec - Université Laval
Locations
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Institut de recherches cliniques de Montréal (IRCM)
Montreal, Quebec, Canada
Centre de recherche du CHU de Québec - Université Laval
Québec, , Canada
Countries
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References
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Coll JC, Garceau E, Leslie WD, Genest M, Michou L, Weisnagel SJ, Mac-Way F, Albert C, Morin SN, Rabasa-Lhoret R, Gagnon C. Prevalence of Vertebral Fractures in Adults With Type 1 Diabetes: DenSiFy Study (Diabetes Spine Fractures). J Clin Endocrinol Metab. 2022 Apr 19;107(5):e1860-e1870. doi: 10.1210/clinem/dgac031.
Other Identifiers
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2019-4550
Identifier Type: -
Identifier Source: org_study_id
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