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Deep Phenotyping of Bone Disease in Type 2 Diabetes and Relations to Diabetic Neuropathy
Sponsor: Aalborg University Hospital
Summary
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
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2023-02-24
Completion Date
2026-04
Last Updated
2024-02-07
Healthy Volunteers
No
Conditions
Interventions
Dual Energy X-ray Absorbtiometry scan
Evaluation of body composition and bone mass density
High-resolution peripheral quantitative computed tomography
High-resolution peripheral quantitative computed tomography (HR-pQCT) assesses both volumetric bone mineral density (vBMD) and trabecular and cortical microarchitecture.
Microindentation
Measures Bone Material Strength Index (BMSi) of cortical bone.
Thermal perception thresholds
Heat and cold perception thresholds
Nerve conduction studies
Nerve conduction and amplitude of sural nerve
Composite Autonomic Symptom Score 31
A validated self-assessment questionnaire quantifying the severity and distribution of autonomic symptoms across six domains (orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder and pupillomotor functions) by scoring 31 clinically selected questions
Skin biopsies with quantification of intra-epidermal nerve fibre density
Skin biopsy
Perception Threshold Tracking
Transcutaneous stimulation of large and small nerve fibres using weak electrical currents
Assessment of cardiovascular autonomic neuropathy
Electrocardiographic recordings at rest and during cardiovascular autonomic reflex tests.
Handgrip strength
Evaluation of muscle strength
Force plate platform
Evaluation of balance while standing still
Biospecimen collection
Biochemistry including bone turnover markers, glycemic status, inflammation markers i.e
Isometric leg extension strength
Evaluation of muscle strength
Michigan Neuropathy Screening Instrument
MNSI is used to assess status of peripheral neuropathy. It includes two separate assessments: a 15-item self-administered questionnaire and a lower extremity examination that includes inspection and assessment of vibratory sensation and ankle reflexes.
Locations (1)
Steno Diabetes Center Nordjylland
Aalborg, Denmark