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

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.

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Key information

Conditions

Type 2 Diabetes Back Injuries Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Fractures, Bone Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Spinal Fractures Spinal Injuries Wounds and Injuries

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Edouard Herriot, Hospices Civisl de Lyon

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone biopsies

Other

Bone biopsies

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: DIABONE

Important dates

Study start: 2017
Primary completion: 2024
Study completion: 2024
First posted: Jun 13, 2016
Registry last updated: May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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