Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes
NCT ID: NCT06351176
Last Updated: 2024-04-08
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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ENROLLING_BY_INVITATION
163 participants
OBSERVATIONAL
2023-07-04
2025-08-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
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 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.
AGEReader
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: 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 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.
AGEReader
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.
Biochemical tests
The investigators perform blood and urine tests in every participant.
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.
AGEReader
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 TSH, hyperparathyroidism, hypoparathyroidism, hypogonadism, acromegaly, Cushing syndrome, adrenal insufficiency);
* Any of these medications since the first DenSiFy study visit : biphosphonates, teriparatide, denosumab, calcitonin, glucocorticoids ≥ 7,5 mg prednisone/day or equivalency ≥ 3 months, aromatase inhibitors, antiandrogens, antiepileptic drugs, anticoagulants, thiazolidinediones;
* Inability to consent.
Healthy controls who have participated in the DenSiFy (Diabetes Spine Fractures) study (NCT04064437)
* As above (as individuals with diabetes), and :
* Diagnosis of diabetes or prediabetes;
* Celiac disease;
* Chronic kidney disease (CrCl \< 60 mL/min).
20 Years
ALL
Yes
Sponsors
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Diabetes Canada
OTHER
CHU de Quebec-Universite Laval
OTHER
Responsible Party
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Claudia Gagnon
MD
Principal Investigators
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Claudia Gagnon, MD
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, Quebec, Canada
Countries
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Other Identifiers
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2024-6819
Identifier Type: -
Identifier Source: org_study_id
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