300
Participants
Start Date
February 24, 2023
Primary Completion Date
April 30, 2026
Study Completion Date
April 30, 2026
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.
RECRUITING
Steno Diabetes Center Nordjylland, Aalborg
Aalborg University Hospital
OTHER