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RECRUITING
NCT05642143

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

Sponsor: Aalborg University Hospital

View on ClinicalTrials.gov

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

Interventions

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.

Locations (1)

Steno Diabetes Center Nordjylland

Aalborg, Denmark