NCT05642143招募中不适用
Deep Phenotyping of Bone Disease in Type 2 Diabetes and Relations to Diabetic Neuropathy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Evaluation of differences in bone turnover markers between T2D patients with and without previous fractures by biochemical analysis of different bone markers (CTX, P1NP, osteocalcin (OC), ucOC, sclerostin, osteoglycin and osteopontin).
研究概览
简要总结
Objectives:
The goal of this cross sectional clinical trial is to examine the phenotype of bone disease in type 2 diabetes.The main aims are to:
- Compare bone microarchitecture, bone biomechanical competence, and bone turnover markers as well as postural control in T2D patients with and without fractures.
- Examine how autonomic and peripheral neuropathy affects bone microarchitecture, bone material strength and bone turnover markers as well as postural control in T2D.
Methods:
The trial is of cross-sectional design and consists of examinations including
- Blood samples to analyze bone markers, glycemic state i.e.
- Bone scans including dual energy x-ray absorptiometry (DXA) and high resolution peripheral quantitative computed tomography (HRpQCT) to evaluate Bone Mineral Density, t-score and bone structure.
- Microindentation to evaluate bone material strength
- Skin autofluorescence to measure levels of advanced glycation endproducts (AGEs) in the skin
- Assesment of nerve function (peripheral and autonomic)
- Assesment of postural control, muscle strength and gait
Participants:
A total of 300 type 2 diabetes patients divided to three groups:
- 160 with no history of fractures or diabetic neuropathy
- 100 with a history of fracture(s)
- 40 with autonomic neuropathy or severe peripheral neuropathy
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with minimum 40 years of age.
- •Diagnosis of T2D. At least one of the following criteria must be met at diagnosis:
- •HbA1c ≥ 48 mmol/mol (6,5 %)
- •Plasma glucose ≥ 11,1 mmol/l
- •Fasting plasma glucose ≥7,0 mmol/l Clinical effect of oral antidiabetic medication strengthens the diagnosis.
- •Diagnosis of diabetes at least one year prior to inclusion of the study to avoid honeymoon diabetes.
- •A history of fracture(s) (confirmed by radiographs analyzed by radiologist) following the diabetes diagnosis (T2D F+ group)
- •Diagnosed with severe peripheral (VPT ≥ 50) or autonomic neuropathy defined by cardiac autonomic reflex tests or severe abnormalities in orthostatic blood pressure (T2D N+ group)
- •Signed the informed consent.
- •Not defined by the exclusion criteria.
排除标准
- •Severe decreased liver function (Alanin amino-transaminase (ALAT) >250 U/l, Gamma-Glutamyltransferase (GGT) >150 U/l).
- •Moderate to severe kidney dysfunction, estimated Glomerular Filtration Rate (eGFR) <15 mmol/L/1,73m
- •Pregnancy or breast feeding.
- •Active malignancy or terminal ill.
- •Previous chemotherapy or immunomodulating treatment
- •Known severe vitamin deficiency
- •Current or previous alcohol- or drug abuse.
- •Not being able to understand Danish written and/or verbally.
- •Terms according to investigators judgement that makes subjects unsuitable to participate including lack of ability to understand and comply with instructions and/or reduced physical ability, limiting the ability to participate in the examinations.
- •Participating in other clinical studies utilizing experimental treatment or medication.
- •Subjects with pathologic fractures (defined as fractures due to local tumors, tumor-like lesions, or focal demineralization as visualized on radiographs).
- •Primary hyperparathyroidism, Paget's disease and other metabolic bone diseases, uncontrolled thyrotoxicosis, celiac disease not controlled by diet, known hypogonadism, severe COPD, hypopituitarism, Cushing's disease.
- •Fracture < 6 month ago
- •Initiation of antiresorptive or bone anabolic drugs <12 months ago to ensure stable bone turnover markers.
- •History of fractures following the diagnosis of diabetes (T2D F-/N- and T2D N+ groups).
- •History of peripheral or autonomic neuropathy defined by cardiac autonomic reflex tests or severe abnormalities in orthostatic blood pressure (T2D F-/N- group).
结局指标
主要结局
Evaluation of differences in bone turnover markers between T2D patients with and without previous fractures by biochemical analysis of different bone markers (CTX, P1NP, osteocalcin (OC), ucOC, sclerostin, osteoglycin and osteopontin).
时间窗: Through study completion, estimated 3.5 years
Evaluation of differences in bone microarchitecture between T2D patients with and without previous fractures assessed by HRpQCT.
时间窗: Through study completion, estimated 3.5 years
Bone microarchitecture is a composite outcome assessed by HRpQCT at radius and tibia: Total volumetric mineral density, Trabecular volumetric mineral density, Cortical volumetric mineral density, Trabecular number, Trabecular thickness, Cortical thickness, Trabecular separation, Cortical porosity, bone stiffness and failure load.
Differences in Bone material strength index (BMSi) between T2D patients with and without previous fractures measured by microindentation.
时间窗: Through study completion, estimated 3.5 years
次要结局
- The impact of autonomic neuropathy on bone material strength in T2D assessed by microindentation.(Through study completion, estimated 3.5 years)
- The impact of autonomic neuropathy on bone turnover markers in T2D.(Through study completion, estimated 3.5 years)
- The impact of peripheral neuropathy on bone turnover markers in T2D.(Through study completion, estimated 3.5 years)
- Compare muscle mass and strength in T2D patients with and without neuropathy(Through study completion, estimated 3.5 years)
- Compare postural control between T2D patients with and without fractures assessed by force platform.(Through study completion, estimated 3.5 years)
- Compare muscle mass and strength in T2D patients with and without fractures(Through study completion, estimated 3.5 years)
- The impact of autonomic neuropathy on bone microarchitecture in T2D assessed by HR-pQCT.(Through study completion, estimated 3.5 years)
- The impact of peripheral neuropathy on bone microarchitecture in T2D assessed by HR-pQCT.(Through study completion, estimated 3.5 years)
- The impact of peripheral neuropathy on bone material strength in T2D assessed by microindentation.(Through study completion, estimated 3.5 years)
- Compare postural control between T2D patients with and without peripheral/autonomic neuropathy.(Through study completion, estimated 3.5 years)
研究者
Julie Lindgård Nielsen
Principal Investigator
Aalborg University Hospital
研究点 (1)
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