NCT02797314Completed
Comparison of Bone Quality in Type 2 Diabetic Patients With a Non-diabetic Control Population
Source: ClinicalTrials.gov · Last updated 8 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 8 Jun 2016
- Start date
- 28 Mar 2017
- Primary completion date
- 8 Mar 2024
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Type 2 diabetes
- NCT number
- NCT02797314
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 28 Mar 2017 to the primary completion date, 8 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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)
Other illness
- Psychiatric pathology seriously hampering understanding
Other
- Pregnant or lactating woman
- Difficulty understanding oral French
- Not a beneficiary of a social security scheme
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Edouard Herriot, Hospices Civisl de Lyon Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.