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Comparison of Bone Quality in Type 2 Diabetic Patients With a Non-diabetic Control Population (DIABONE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02797314
Recruitment Status : Recruiting
First Posted : June 13, 2016
Last Update Posted : January 23, 2019
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: Bone biopsies Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison of Bone Quality in Type 2 Diabetic Patients With a Non-diabetic Control Population
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Type 2 diabetic population
Bone biopsies
Other: Bone biopsies
Bone biopsies

Non-diabetic control population
Bone biopsies
Other: Bone biopsies
Bone biopsies

Primary Outcome Measures :
  1. Bone mineral density [ Time Frame: 1 month after patient inclusion ]
    Bone mineral density (BMD) measured by Dual-energy X-ray absorptiometry (DXA)

  2. Vertebral fractures [ Time Frame: 1 month after patient inclusion ]
    Presence of vertebral fractures evaluated by Vertebral Fracture Assessment (VFA)

  3. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 ≥ -1,5)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02797314

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Contact: Julien WEGRZYN, MD 4 72 11 04 43 ext +33
Contact: Delphine FARLAY 4 78 77 57 35 ext +33

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Hôpital Edouard Herriot, Hospices Civisl de Lyon Recruiting
Lyon, France, 69437
Contact: Julien WEGRZYN, MD         
Principal Investigator: Julien WEGRZYN, MD         
Hôpital Nord, CHU de Saint-Etienne Recruiting
Saint-Etienne, France, 42055
Contact: Marie-Hélène LAFAGE-PROUST, MD         
Principal Investigator: Marie-Hélène LAFAGE-PROUST, MD         
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon Identifier: NCT02797314     History of Changes
Other Study ID Numbers: 69HCL16_0092
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Type 2 diabetes
Bone quality
Bone biopsies
Vertebral fractures
Trabecular Bone Score

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases