Diabetes Mellitus, Type 1DenSiFy cohortNCT06351176
Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1 and Bone Health, run by CHU de Quebec-Universite Laval at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1, Bone Health, Bone Loss
- What is being tested?
- Clinical tests, Biochemical tests and DXA scan with TBS and VFA
- How many people
- 163 participants
- Where
- 2 sitesCanada
- Study dates
- 4 Jul 2023to 29 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 127 individuals with type 1 diabetes and 65 healthy subjects from the DenSiFy (Diabetes Spine Fractures) study (NCT04064437)
Who may be able to join
- Diagnosis of type 1 diabetes for at least 5 years;
- Age 20 years and older.
- Age 20 years and older.
Who cannot join
- Pregnancy, delivery or breastfeeding in the past 6 months;
- 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 :
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- Diagnosis of diabetes or prediabetes;
- Celiac disease;
- Chronic kidney disease (CrCl < 60 mL/min).
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Institut de recherches cliniques de Montréal (IRCM)
Montreal, Quebec, H2W 1R7
Centre de recherche du CHU de Québec-Université Laval
Québec, Quebec, G1V 4G2
About this study
Official title: Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes : DenSiFy (Diabetes Spine Fractures) Cohort
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
- Being tested
- Clinical tests, Biochemical tests, DXA scan with TBS and VFA, AGEReader
- Medical subject headings
- Diabetes Mellitus, Type 1, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical testsDiagnostic test
The investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant.
Biochemical testsDiagnostic test
The investigators perform blood and urine tests in every participant.
DXA scan with TBS and VFADiagnostic test
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.
AGEReaderDiagnostic test
The investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine in every participant.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with type 1 diabetes | Not described Receives: Diagnostic Test: Clinical tests; Diagnostic Test: Biochemical tests; Diagnostic Test: DXA scan with TBS and VFA; Diagnostic Test: AGEReader | |
| Healthy controls | Not described Receives: Diagnostic Test: Clinical tests; Diagnostic Test: Biochemical tests; Diagnostic Test: DXA scan with TBS and VFA; Diagnostic Test: AGEReader |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in areal bone mineral density (aBMD) at the femoral neck in g/cm2
aBMD measured by DXA scan
Measured: Between the baseline and the 4-year visit
Secondary outcomes (7)
Change in areal bone mineral density (aBMD) at the spine in g/cm2
aBMD measured by DXA scan
Measured: Between the baseline and the 4-year visit
Change in areal bone mineral density (aBMD) at the total hip in g/cm2
aBMD measured by DXA scan
Measured: Between the baseline and the 4-year visit
Change in areal bone mineral density (aBMD) at the distal third of radius in g/cm2
aBMD measured by DXA scan
Measured: Between the baseline and the 4-year visit
Change in Trabecular bone score (TBS) (unitless)
TBS with the software TBSinSight
Measured: Between the baseline and the 4-year visit
Glycemic control, assessed with mean glycated hemoglobin (HbA1c) of the past 7 years
Mean HbA1c of the past 7 years from all the available HbA1c in the medical record
Measured: 4-year visit
Glycemic control, assessed with skin advanced glycation end products (AGEs)
Skin AGEs measured with AGEReader (autofluorescence)
Measured: 4-year visit
Presence of a microvascular complication (neuropathy, nephropathy, retinopathy)
From the information available in the medical record and from monofilament and vibration testing (for neuropathy) and from microalbuminuria (nephropathy)
Measured: 4-year visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start4 Jul 2023
- Primary completion22 Dec 2024 (estimated)
- Study completion29 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 163 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes Canada
- Responsible party
- Principal investigator, Claudia Gagnon, CHU de Quebec-Universite Laval
- Investigators
- Claudia Gagnon, MD, Principal investigator, CHU de Québec- Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351176
- Sponsor's protocol ID
- 2024-6819
- Acronym
- DenSiFy cohort
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes : DenSiFy (Diabetes Spine Fractures) Cohort
- ClinicalTrials.gov ID
- NCT06351176
- Acronym / sponsor ID
- DenSiFy cohort / 2024-6819
- Conditions
- Diabetes Mellitus, Type 1, Bone Health, Bone Loss, Bone Diseases, Metabolic, Hyperglycaemia Due to Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 163 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Diabetes Canada
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 22 Dec 2024 (estimated)
- Study completion
- 29 Aug 2025 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with type 1 diabetes | – | Diagnostic Test: Clinical tests, Diagnostic Test: Biochemical tests, Diagnostic Test: DXA scan with TBS and VFA, Diagnostic Test: AGEReader |
| Healthy controls | – | Diagnostic Test: Clinical tests, Diagnostic Test: Biochemical tests, Diagnostic Test: DXA scan with TBS and VFA, Diagnostic Test: AGEReader |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 127 individuals with type 1 diabetes and 65 healthy subjects from the DenSiFy (Diabetes Spine Fractures) study (NCT04064437)
Key inclusion criteria (3 listed)
- Diagnosis of type 1 diabetes for at least 5 years;
- Age 20 years and older.
- Age 20 years and older.
Key exclusion criteria (9 listed)
- Pregnancy, delivery or breastfeeding in the past 6 months;
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical testsThe investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant. | Diagnostic test | Healthy controls, Individuals with type 1 diabetes |
| Biochemical testsThe investigators perform blood and urine tests in every participant. | Diagnostic test | Healthy controls, Individuals with type 1 diabetes |
| DXA scan with TBS and VFAThe 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 | Healthy controls, Individuals with type 1 diabetes |
| AGEReaderThe investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine in every participant. | Diagnostic test | Healthy controls, Individuals with type 1 diabetes |
Primary outcome
Change in areal bone mineral density (aBMD) at the femoral neck in g/cm2
Time frame: Between the baseline and the 4-year visit
aBMD measured by DXA scan
7 secondary outcomes
Change in areal bone mineral density (aBMD) at the spine in g/cm2
Time frame: Between the baseline and the 4-year visit
Change in areal bone mineral density (aBMD) at the total hip in g/cm2
Time frame: Between the baseline and the 4-year visit
Change in areal bone mineral density (aBMD) at the distal third of radius in g/cm2
Time frame: Between the baseline and the 4-year visit
Change in Trabecular bone score (TBS) (unitless)
Time frame: Between the baseline and the 4-year visit
Glycemic control, assessed with mean glycated hemoglobin (HbA1c) of the past 7 years
Time frame: 4-year visit
Glycemic control, assessed with skin advanced glycation end products (AGEs)
Time frame: 4-year visit
Presence of a microvascular complication (neuropathy, nephropathy, retinopathy)
Time frame: 4-year visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Gagnon, MD principal investigator
CHU de Québec- Université Laval
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Bone Health, run by CHU de Quebec-Universite Laval at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in areal bone mineral density (aBMD) at the femoral neck in g/cm2 (time frame: Between the baseline and the 4-year visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.