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NCT06351176: DenSiFy cohort
Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes
trial testing Clinical tests in Diabetes Mellitus, Type 1 in 163 participants. Enrolling by invitation.
22 December 2024
Quick facts
| Lead sponsor | CHU de Quebec-Universite Laval |
|---|---|
| Status | ENROLLING BY INVITATION |
| Study type | OBSERVATIONAL |
| Enrollment | 163 |
| Start date | 4 July 2023 |
| Primary completion | 22 December 2024 |
| Estimated completion | 29 August 2025 |
| Sites | 2 locations across Canada |
Drugs / interventions tested
- Clinical tests
- Biochemical tests
- DXA scan with TBS and VFA
- AGEReader
Conditions studied
- Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
- Bone Health — all drugs for Bone Health →
- Bone Loss — all drugs for Bone Loss →
- Bone Diseases, Metabolic — all drugs for Bone Diseases, Metabolic →
Sponsor
CHU de Quebec-Universite Laval — full company profile →
Who can join
20 and older, any sex, with Diabetes Mellitus, Type 1 or Bone Health. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06351176
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Diabetes Mellitus, Type 1
Currently open trials in the same condition.
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Other CHU de Quebec-Universite Laval trials
Trials by the same sponsor.
- NCT07067827 — Self-questionnaire in Osteoporosis · recruiting
- NCT06018116 — A Canadian Trial of Bicalutamide in Patients Receiving Maintenance Avelumab for Metastatic Urothelial Cancer. · Phase 2 · withdrawn
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- NCT05859139 — Scaling a Decision Aid on Prenatal Screening for Trisomy 21, 18 and 13 · NA · completed
- NCT06547515 — Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06351176 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CHU de Quebec-Universite Laval
- Last refreshed: 8 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06351176.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing