NCT05642143

Deep Phenotyping of Bone Disease in Type 2 Diabetes and Relations to Diabetic Neuropathy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Aalborg University Hospital · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Conditions

• Type 2 Diabetes
• Bone Disease
• Osteoporosis
• Diabetic Neuropathy Peripheral
• Autonomic Neuropathy, Diabetic

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Dual Energy X-ray Absorbtiometry scan	Evaluation of body composition and bone mass density
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	Microindentation	Measures Bone Material Strength Index (BMSi) of cortical bone.
DIAGNOSTIC_TEST	Thermal perception thresholds	Heat and cold perception thresholds
DIAGNOSTIC_TEST	Nerve conduction studies	Nerve conduction and amplitude of sural nerve
DIAGNOSTIC_TEST	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
DIAGNOSTIC_TEST	Skin biopsies with quantification of intra-epidermal nerve fibre density	Skin biopsy
DIAGNOSTIC_TEST	Perception Threshold Tracking	Transcutaneous stimulation of large and small nerve fibres using weak electrical currents
DIAGNOSTIC_TEST	Assessment of cardiovascular autonomic neuropathy	Electrocardiographic recordings at rest and during cardiovascular autonomic reflex tests.
DIAGNOSTIC_TEST	Handgrip strength	Evaluation of muscle strength
DIAGNOSTIC_TEST	Force plate platform	Evaluation of balance while standing still
DIAGNOSTIC_TEST	Biospecimen collection	Biochemistry including bone turnover markers, glycemic status, inflammation markers i.e
DIAGNOSTIC_TEST	Isometric leg extension strength	Evaluation of muscle strength
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2023-02-24
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2022-12-08
• Last updated: 2024-02-07

Locations

1 site across 1 country: Denmark