RecruitingNCT05642143

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


Sponsor

Aalborg University Hospital

Enrollment

300 participants

Start Date

Feb 24, 2023

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating bone disease in people with Type 2 diabetes, looking at why diabetics have a higher risk of fractures even when their bone density appears normal. It also examines whether nerve damage (neuropathy) affects bone health in this group. **You may be eligible if...** - You are a man or woman aged 40 or older - You have a confirmed diagnosis of Type 2 diabetes for at least 1 year - You either have a history of fracture after your diabetes diagnosis, OR have been diagnosed with severe peripheral or autonomic neuropathy (nerve damage) **You may NOT be eligible if...** - You have other conditions that significantly affect bone health (such as severe kidney disease, rheumatoid arthritis, or prolonged steroid use) - You have Type 1 diabetes - You are unable to participate in the study assessments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTDual Energy X-ray Absorbtiometry scan

Evaluation of body composition and bone mass density

DIAGNOSTIC_TESTHigh-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_TESTMicroindentation

Measures Bone Material Strength Index (BMSi) of cortical bone.

DIAGNOSTIC_TESTThermal perception thresholds

Heat and cold perception thresholds

DIAGNOSTIC_TESTNerve conduction studies

Nerve conduction and amplitude of sural nerve

DIAGNOSTIC_TESTComposite 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_TESTSkin biopsies with quantification of intra-epidermal nerve fibre density

Skin biopsy

DIAGNOSTIC_TESTPerception Threshold Tracking

Transcutaneous stimulation of large and small nerve fibres using weak electrical currents

DIAGNOSTIC_TESTAssessment of cardiovascular autonomic neuropathy

Electrocardiographic recordings at rest and during cardiovascular autonomic reflex tests.

DIAGNOSTIC_TESTHandgrip strength

Evaluation of muscle strength

DIAGNOSTIC_TESTForce plate platform

Evaluation of balance while standing still

DIAGNOSTIC_TESTBiospecimen collection

Biochemistry including bone turnover markers, glycemic status, inflammation markers i.e

DIAGNOSTIC_TESTIsometric leg extension strength

Evaluation of muscle strength

DIAGNOSTIC_TESTMichigan 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

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NCT05642143


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