Type 2 DiabetesDIABONENCT02797314
Comparison of Bone Quality in Type 2 Diabetic Patients With a Non-diabetic Control Population
A study testing Bone biopsies in people with Type 2 Diabetes, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Patients with type 2 diabetes have many complications in different organs. These complications are extremely frequent and severe: cardiovascular and renal disease, visual impairment, and, more recently, complications affecting bone such as fractures. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Bone biopsies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 28 Mar 2017to 8 Mar 2024
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged greater than 40 years
- Patients requiring surgery of the lower limb
- With a bone mineral density considered normal (T-score ≥ -2)
- Stage 1, 2, or 3 glomerular filtration rate (> 30 mL/min)
- For diabetic patients the diagnosis will have previously established by an endocrinologist
Who cannot join
- Subjects treated with drugs known to interfere with bone metabolism, including steroids, anticonvulsants, diuretics, and bisphosphonates
- Patients with severe renal disease (< 30 ml/mn); previous history of caner except skin cancer; myocardial infarction; uncontrolled hypertension; untreated hyperthyroidism; hyperthyroidism; malabsorption; bone metabolism diseases; rheumatoid arthritis or collagen diseases
- Pregnant or lactating woman
- Contraindication to taking tetracycline hydrochloride:
- Known hypersensitivity to antibiotics of the tetracycline family or any of the excipients in the medicine
- Severe chronic renal failure
Show all 12Show fewer
- Chronic liver failure
- Systemic lupus erythematosus
- Concomitant prescription of retinoid or vitamin A (risk intracranial hypertension)
- Psychiatric pathology seriously hampering understanding
- Difficulty understanding oral French
- Not a beneficiary of a social security scheme
Trial locations and contacts
1 site in 1 country.
About this study
Patients with type 2 diabetes have many complications in different organs. These complications are extremely frequent and severe: cardiovascular and renal disease, visual impairment, and, more recently, complications affecting bone such as fractures. Conventional methods for the evaluation of fracture risk are based on the Bone Mineral Density (BMD) or FRAX (algorithm for the prediction of osteoporotic fracture risk) are not sufficient in the context of diabetes. Several metaanalyses have shown that, paradoxically, a higher BMD in patients with type 2 diabetes compared to patients not suffering from this disease, independently of body mass index (BMI). The paradoxal increase in fracture risk, despite a high BMD has led to the hypothesis that diabetes induces a modification of the quality and not the quantity of bone. However, there is a lack of data as to bone quality in patients with type 2 diabetes as studies of bone biopsies from patients with type 2 diabetes are extremely rare.
The objective of the study is to compare bone quality in patients with type 2 diabetes to that in patients who do not suffer from type 2 diabetes: evaluation of vertebral fractures by osteodensitometry, measurement of Trabecular Bone Score (TBS), and analysis of bone quality in biopsies (advanced glycation end products (AGE), contents of bone matrix and analysis of mineralization).
The results will then be correlated with blood/urinary markers with the objective to determine one/several non-invasive biomarkers for bone status in diabetic patients.
- Conditions
- Type 2 Diabetes
- Being tested
- Bone biopsies
- Keywords
- Type 2 diabetes, Bone quality, Bone biopsies, Vertebral fractures, Osteodensitometry, Trabecular Bone Score
- Medical subject headings
- Diabetes Mellitus, Type 2, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone biopsiesOther
Bone biopsies
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetic population | Other | Bone biopsies Receives: Other: Bone biopsies |
| Non-diabetic control population | Other | Bone biopsies Receives: Other: Bone biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Bone mineral density (BMD) measured by Dual-energy X-ray absorptiometry (DXA)
Measured: 1 month after patient inclusion
Vertebral fractures
Presence of vertebral fractures evaluated by Vertebral Fracture Assessment (VFA)
Measured: 1 month after patient inclusion
Trabecular Bone Score
Trabecular bone score (TBS) is a analytical tool that performs novel grey-level texture measurements on lumbar spine dual X-ray absorptiometry (DXA) images, and thereby captures information relating to trabecular microarchitecture
Measured: 1 month after patient inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study start28 Mar 2017
- Primary completion8 Mar 2024
- Study completion8 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797314
- Sponsor's protocol ID
- 69HCL16_0092
- Other IDs
- 2016-A01228-43
- Acronym
- DIABONE
- Status last verified
- May 2024
- First submitted
- 8 Jun 2016
- Last updated
- 8 May 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 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bone Quality in Type 2 Diabetic Patients With a Non-diabetic Control Population
- ClinicalTrials.gov ID
- NCT02797314
- Acronym / sponsor ID
- DIABONE / 69HCL16_0092
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Bone quality, Bone biopsies, Vertebral fractures, Osteodensitometry, Trabecular Bone Score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 13 Jun 2016 (estimated)
- 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.
Patients with type 2 diabetes have many complications in different organs. These complications are extremely frequent and severe: cardiovascular and renal disease, visual impairment, and, more recently, complications affecting bone such as fractures. Conventional methods for the evaluation of fracture risk are based on the Bone Mineral Density (BMD) or FRAX (algorithm for the prediction of osteoporotic fracture risk) are not sufficient in the context of diabetes. Several metaanalyses have shown that, paradoxically, a higher BMD in patients with type 2 diabetes compared to patients not suffering from this disease, independently of body mass index (BMI). The paradoxal increase in fracture risk, despite a high BMD has led to the hypothesis that diabetes induces a modification of the quality and not the quantity of bone. However, there is a lack of data as to bone quality in patients with type 2 diabetes as studies of bone biopsies from patients with type 2 diabetes are extremely rare.
The objective of the study is to compare bone quality in patients with type 2 diabetes to that in patients who do not suffer from type 2 diabetes: evaluation of vertebral fractures by osteodensitometry, measurement of Trabecular Bone Score (TBS), and analysis of bone quality in biopsies (advanced glycation end products (AGE), contents of bone matrix and analysis of mineralization).
The results will then be correlated with blood/urinary markers with the objective to determine one/several non-invasive biomarkers for bone status in diabetic patients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetic population | Other | Other: Bone biopsiesBone biopsies |
| Non-diabetic control population | Other | Other: Bone biopsiesBone biopsies |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged greater than 40 years
- Patients requiring surgery of the lower limb
- With a bone mineral density considered normal (T-score ≥ -2)
- Stage 1, 2, or 3 glomerular filtration rate (> 30 mL/min)
- For diabetic patients the diagnosis will have previously established by an endocrinologist
Key exclusion criteria (12 listed)
- Subjects treated with drugs known to interfere with bone metabolism, including steroids, anticonvulsants, diuretics, and bisphosphonates
- Patients with severe renal disease (< 30 ml/mn); previous history of caner except skin cancer; myocardial infarction; uncontrolled hypertension; untreated hyperthyroidism; hyperthyroidism; malabsorption; bone metabolism diseases; rheumatoid arthritis or collagen diseases
- Pregnant or lactating woman
- Contraindication to taking tetracycline hydrochloride:
- Psychiatric pathology seriously hampering understanding
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 |
|---|---|---|
| Bone biopsiesBone biopsies | Other | Non-diabetic control population, Type 2 diabetic population |
Primary outcome
Bone mineral density
Time frame: 1 month after patient inclusion
Bone mineral density (BMD) measured by Dual-energy X-ray absorptiometry (DXA)
Vertebral fractures
Time frame: 1 month after patient inclusion
Presence of vertebral fractures evaluated by Vertebral Fracture Assessment (VFA)
Trabecular Bone Score
Time frame: 1 month after patient inclusion
Trabecular bone score (TBS) is a analytical tool that performs novel grey-level texture measurements on lumbar spine dual X-ray absorptiometry (DXA) images, and thereby captures information relating to trabecular microarchitecture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone biopsies in people with Type 2 Diabetes, run by Hospices Civils de Lyon at 1 site in France.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bone mineral density (time frame: 1 month after patient inclusion). The study lists 3 primary outcomes in all. 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 May 2024.