Comparison of Bone Quality in Type 2 Diabetic Patients With a Non-diabetic Control Population (DIABONE)
Primary Purpose
Type 2 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bone biopsies
Sponsored by
About this trial
This is an interventional other trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Bone quality, Bone biopsies, Vertebral fractures, Osteodensitometry, Trabecular Bone Score
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Hôpital Edouard Herriot, Hospices Civisl de LyonRecruiting
- Hôpital Nord, CHU de Saint-Etienne
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Type 2 diabetic population
Non-diabetic control population
Arm Description
Bone biopsies
Bone biopsies
Outcomes
Primary Outcome Measures
Bone mineral density
Bone mineral density (BMD) measured by Dual-energy X-ray absorptiometry (DXA)
Vertebral fractures
Presence of vertebral fractures evaluated by Vertebral Fracture Assessment (VFA)
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02797314
Brief Title
Comparison of Bone Quality in Type 2 Diabetic Patients With a Non-diabetic Control Population
Acronym
DIABONE
Official Title
Comparison of Bone Quality in Type 2 Diabetic Patients With a Non-diabetic Control Population
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2017 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes, Bone quality, Bone biopsies, Vertebral fractures, Osteodensitometry, Trabecular Bone Score
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Type 2 diabetic population
Arm Type
Other
Arm Description
Bone biopsies
Arm Title
Non-diabetic control population
Arm Type
Other
Arm Description
Bone biopsies
Intervention Type
Other
Intervention Name(s)
Bone biopsies
Intervention Description
Bone biopsies
Primary Outcome Measure Information:
Title
Bone mineral density
Description
Bone mineral density (BMD) measured by Dual-energy X-ray absorptiometry (DXA)
Time Frame
1 month after patient inclusion
Title
Vertebral fractures
Description
Presence of vertebral fractures evaluated by Vertebral Fracture Assessment (VFA)
Time Frame
1 month after patient inclusion
Title
Trabecular Bone Score
Description
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
Time Frame
1 month after patient inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuelle VIGNOT, MD
Phone
4 72 11 74 91
Ext
+33
Email
emmanuelle.vignot@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Delphine FARLAY
Phone
4 78 77 57 35
Ext
+33
Email
delphine.farlay@inserm.fr
Facility Information:
Facility Name
Hôpital Edouard Herriot, Hospices Civisl de Lyon
City
Lyon
ZIP/Postal Code
69437
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle VIGNOT, MD
First Name & Middle Initial & Last Name & Degree
Emmanuelle VIGNOT, MD
Facility Name
Hôpital Nord, CHU de Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Withdrawn
12. IPD Sharing Statement
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Comparison of Bone Quality in Type 2 Diabetic Patients With a Non-diabetic Control Population
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