Type 2 Diabetes Clinical Trial
Official title:
Deep Phenotyping of Bone Disease in Type 2 Diabetes and Relations to Diabetic Neuropathy
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: 1. Compare bone microarchitecture, bone biomechanical competence, and bone turnover markers as well as postural control in T2D patients with and without fractures. 2. 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
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