Type 2 DiabetesNCT05642143
Deep Phenotyping of Bone Disease in Type 2 Diabetes and Relations to Diabetic Neuropathy
An observational study of Type 2 Diabetes and Bone Disease, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Type 2 Diabetes, Bone Disease, Osteoporosis
- What is being tested?
- Dual Energy X-ray Absorbtiometry scan, High-resolution peripheral quantitative computed tomography and Microindentation
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Feb 2023to Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: T2D with and without fractures and neuropathy.
Who may be able to join
- Men and women with minimum 40 years of age.
- Diagnosis of T2D. At least one of the following criteria must be met at diagnosis:
- HbA1c ≥ 48 mmol/mol (6,5 %)
- Plasma glucose ≥ 11,1 mmol/l
- Fasting plasma glucose ≥7,0 mmol/l Clinical effect of oral antidiabetic medication strengthens the diagnosis.
- Diagnosis of diabetes at least one year prior to inclusion of the study to avoid honeymoon diabetes.
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- A history of fracture(s) (confirmed by radiographs analyzed by radiologist) following the diabetes diagnosis (T2D F+ group)
- Diagnosed with severe peripheral (VPT ≥ 50) or autonomic neuropathy defined by cardiac autonomic reflex tests or severe abnormalities in orthostatic blood pressure (T2D N+ group)
- Signed the informed consent.
- Not defined by the exclusion criteria.
Who cannot join
- Severe decreased liver function (Alanin amino-transaminase (ALAT) >250 U/l, Gamma-Glutamyltransferase (GGT) >150 U/l).
- Moderate to severe kidney dysfunction, estimated Glomerular Filtration Rate (eGFR) <15 mmol/L/1,73m2.
- Pregnancy or breast feeding.
- Active malignancy or terminal ill.
- Previous chemotherapy or immunomodulating treatment
- Known severe vitamin deficiency
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- Current or previous alcohol- or drug abuse.
- Not being able to understand Danish written and/or verbally.
- Terms according to investigators judgement that makes subjects unsuitable to participate including lack of ability to understand and comply with instructions and/or reduced physical ability, limiting the ability to participate in the examinations.
- Participating in other clinical studies utilizing experimental treatment or medication.
- Subjects with pathologic fractures (defined as fractures due to local tumors, tumor-like lesions, or focal demineralization as visualized on radiographs).
- Primary hyperparathyroidism, Paget's disease and other metabolic bone diseases, uncontrolled thyrotoxicosis, celiac disease not controlled by diet, known hypogonadism, severe COPD, hypopituitarism, Cushing's disease.
- Fracture < 6 month ago
- Initiation of antiresorptive or bone anabolic drugs <12 months ago to ensure stable bone turnover markers.
- History of fractures following the diagnosis of diabetes (T2D F-/N- and T2D N+ groups).
- History of peripheral or autonomic neuropathy defined by cardiac autonomic reflex tests or severe abnormalities in orthostatic blood pressure (T2D F-/N- group).
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Steno Diabetes Center Nordjylland
Aalborg, 9000
Julie Lindgård Graversen, MD
About this study
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:
Read more
- Compare bone microarchitecture, bone biomechanical competence, and bone turnover markers as well as postural control in T2D patients with and without fractures.
- 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
- Being tested
- Dual Energy X-ray Absorbtiometry scan, High-resolution peripheral quantitative computed tomography, Microindentation, Thermal perception thresholds, Nerve conduction studies
- Medical subject headings
- Diabetes Mellitus, Type 2, Bone Diseases, Osteoporosis, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Energy X-ray Absorbtiometry scanDiagnostic test
Also called DXA
Evaluation of body composition and bone mass density
High-resolution peripheral quantitative computed tomographyDiagnostic test
Also called HR-pQCT
High-resolution peripheral quantitative computed tomography (HR-pQCT) assesses both volumetric bone mineral density (vBMD) and trabecular and cortical microarchitecture.
MicroindentationDiagnostic test
Also called Osteoprobe, ActiveLife, Santa Barbara, CA
Measures Bone Material Strength Index (BMSi) of cortical bone.
Thermal perception thresholdsDiagnostic test
Also called Quantitative Sensory Testing
Heat and cold perception thresholds
Nerve conduction studiesDiagnostic test
Also called NCStat-DPN-Check
Nerve conduction and amplitude of sural nerve
Composite Autonomic Symptom Score 31Diagnostic test
Also called COMPASS 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 densityDiagnostic test
Also called PGP9.5, antibodies for subsets of ion-channels ect
Skin biopsy
Perception Threshold TrackingDiagnostic test
Also called PTT
Transcutaneous stimulation of large and small nerve fibres using weak electrical currents
Assessment of cardiovascular autonomic neuropathyDiagnostic test
Also called Vagus device, Medicus Engineering ApS, Aarhus, Denmark
Electrocardiographic recordings at rest and during cardiovascular autonomic reflex tests.
Handgrip strengthDiagnostic test
Also called Hydraulic dynamometer, Saehan Corporation, Gyungnam, South Korea
Evaluation of muscle strength
Force plate platformDiagnostic test
Also called Plux Biosignals, S.A, Arruda dos Vinhos, Portugal
Evaluation of balance while standing still
Biospecimen collectionDiagnostic test
Also called Blood samples, Urine samples
Biochemistry including bone turnover markers, glycemic status, inflammation markers i.e
Isometric leg extension strengthDiagnostic test
Also called EasyForce Digital Dynamometer
Evaluation of muscle strength
Michigan Neuropathy Screening InstrumentDiagnostic test
Also called MNSI
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.
| Study group | Role | What they receive |
|---|---|---|
| T2D F-/N- | Subjects with T2D and no previous history of any fractures or diabetic neuropathy (n=160) Receives: Diagnostic Test: Dual Energy X-ray Absorbtiometry scan; Diagnostic Test: High-resolution peripheral quantitative computed tomography; Diagnostic Test: Microindentation; Diagnostic Test: Thermal perception thresholds; Diagnostic Test: Nerve conduction studies; Diagnostic Test: Composite Autonomic Symptom Score 31; Diagnostic Test: Skin biopsies with quantification of intra-epidermal nerve fibre density; Diagnostic Test: Perception Threshold Tracking; Diagnostic Test: Assessment of cardiovascular autonomic neuropathy; Diagnostic Test: Handgrip strength; Diagnostic Test: Force plate platform; Diagnostic Test: Biospecimen collection; Diagnostic Test: Isometric leg extension strength; Diagnostic Test: Michigan Neuropathy Screening Instrument | |
| T2D F+ | Subjects with T2D with a previous history of a fracture(s) (any fracture, major osteoporotic fracture (MOF) and peripheral) (n=100) Receives: Diagnostic Test: Dual Energy X-ray Absorbtiometry scan; Diagnostic Test: High-resolution peripheral quantitative computed tomography; Diagnostic Test: Microindentation; Diagnostic Test: Thermal perception thresholds; Diagnostic Test: Nerve conduction studies; Diagnostic Test: Composite Autonomic Symptom Score 31; Diagnostic Test: Perception Threshold Tracking; Diagnostic Test: Assessment of cardiovascular autonomic neuropathy; Diagnostic Test: Handgrip strength; Diagnostic Test: Force plate platform; Diagnostic Test: Biospecimen collection; Diagnostic Test: Isometric leg extension strength; Diagnostic Test: Michigan Neuropathy Screening Instrument | |
| T2D N+ | Subjects with T2D matched by age and sex with severe peripheral (vibration perception threshold (VPT) > 50) or a history of autonomic neuropathy (n=40) Receives: Diagnostic Test: Dual Energy X-ray Absorbtiometry scan; Diagnostic Test: High-resolution peripheral quantitative computed tomography; Diagnostic Test: Microindentation; Diagnostic Test: Thermal perception thresholds; Diagnostic Test: Nerve conduction studies; Diagnostic Test: Composite Autonomic Symptom Score 31; Diagnostic Test: Skin biopsies with quantification of intra-epidermal nerve fibre density; Diagnostic Test: Perception Threshold Tracking; Diagnostic Test: Assessment of cardiovascular autonomic neuropathy; Diagnostic Test: Handgrip strength; Diagnostic Test: Force plate platform; Diagnostic Test: Biospecimen collection; Diagnostic Test: Isometric leg extension strength; Diagnostic Test: Michigan Neuropathy Screening Instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of differences in bone microarchitecture between T2D patients with and without previous fractures assessed by HRpQCT.
Bone microarchitecture is a composite outcome assessed by HRpQCT at radius and tibia: Total volumetric mineral density, Trabecular volumetric mineral density, Cortical volumetric mineral density, Trabecular number, Trabecular thickness, Cortical thickness, Trabecular separation, Cortical porosity, bone stiffness and failure load.
Measured: Through study completion, estimated 3.5 years
Differences in Bone material strength index (BMSi) between T2D patients with and without previous fractures measured by microindentation.
Measured: Through study completion, estimated 3.5 years
Evaluation of differences in bone turnover markers between T2D patients with and without previous fractures by biochemical analysis of different bone markers (CTX, P1NP, osteocalcin (OC), ucOC, sclerostin, osteoglycin and osteopontin).
Measured: Through study completion, estimated 3.5 years
Secondary outcomes (10)
The impact of autonomic neuropathy on bone microarchitecture in T2D assessed by HR-pQCT.
Compare bone microarchitectural parameters (assessed by HR-pQCT) in T2D patients with and without autonomic neuropathy (assessed by CAN-score from Vagus™ device, COMPASS31-score, intraepidermal nerve fiber density, orthostatic BP and ECG).
Measured: Through study completion, estimated 3.5 years
The impact of autonomic neuropathy on bone material strength in T2D assessed by microindentation.
Compare bone material strength (assessed by microindentation) in T2D patients with and without autonomic neuropathy (assessed by CAN-score from Vagus™ device, COMPASS31-score, intraepidermal nerve fiber density, orthostatic BP and ECG).
Measured: Through study completion, estimated 3.5 years
The impact of autonomic neuropathy on bone turnover markers in T2D.
Compare bone turnover markers in T2D patients with and without autonomic neuropathy (assessed by CAN-score from Vagus™ device, COMPASS31-score, intraepidermal nerve fiber density, orthostatic BP and ECG)
Measured: Through study completion, estimated 3.5 years
The impact of peripheral neuropathy on bone microarchitecture in T2D assessed by HR-pQCT.
Compare bone microarchitectural parameters (assessed by HR-pQCT) in T2D patients with and without peripheral neuropathy (assessed by MNSI, PTT, QST, sural nerve conduction study and intraepidermal nerve fiber density)
Measured: Through study completion, estimated 3.5 years
The impact of peripheral neuropathy on bone material strength in T2D assessed by microindentation.
Compare bone material strength (assessed by microindentation) in T2D patients with and without peripheral neuropathy (assessed by MNSI, PTT, QST, sural nerve conduction study and intraepidermal nerve fiber density)
Measured: Through study completion, estimated 3.5 years
The impact of peripheral neuropathy on bone turnover markers in T2D.
Compare bone turnover markers in T2D patients with and without peripheral neuropathy (assessed by MNSI, PTT, QST, sural nerve conduction study and intraepidermal nerve fiber density).
Measured: Through study completion, estimated 3.5 years
Compare postural control between T2D patients with and without fractures assessed by force platform.
Measured: Through study completion, estimated 3.5 years
Compare postural control between T2D patients with and without peripheral/autonomic neuropathy.
Neuropathy assessed by PTT, QST, sural nerve conduction study, skin biopsies, COMPASS-31, MNSI and Vagus device. Postural control assessed by force platform.
Measured: Through study completion, estimated 3.5 years
Compare muscle mass and strength in T2D patients with and without fractures
Compare muscle mass (assessed by DXA scan) and muscle strength (assessed by hand grip, leg extension strength and functional tests) in T2D patients with and without fractures.
Measured: Through study completion, estimated 3.5 years
Compare muscle mass and strength in T2D patients with and without neuropathy
Compare muscle mass (assessed by DXA scan) and muscle strength (assessed by hand grip, leg extension strength and functional tests) in T2D patients with and without neuropathy (assessed by PTT, QST, sural nerve conduction study, skin biopsies, COMPASS-31, MNSI and Vagus device).
Measured: Through study completion, estimated 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start24 Feb 2023
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Lindgård Nielsen, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642143
- Sponsor's protocol ID
- N-20220038
- Status last verified
- Feb 2024
- First submitted
- 4 Nov 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Potential analysis of skin biopsies in external lab
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Phenotyping of Bone Disease in Type 2 Diabetes and Relations to Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT05642143
- Acronym / sponsor ID
- N-20220038
- Conditions
- Type 2 Diabetes, Bone Disease, Osteoporosis, Diabetic Neuropathy Peripheral, Autonomic Neuropathy, Diabetic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Compare bone microarchitecture, bone biomechanical competence, and bone turnover markers as well as postural control in T2D patients with and without fractures.
- 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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T2D F-/N- | – | Diagnostic Test: Dual Energy X-ray Absorbtiometry scan, Diagnostic Test: High-resolution peripheral quantitative computed tomography, Diagnostic Test: Microindentation, Diagnostic Test: Thermal perception thresholds, Diagnostic Test: Nerve conduction studies, Diagnostic Test: Composite Autonomic Symptom Score 31, Diagnostic Test: Skin biopsies with quantification of intra-epidermal nerve fibre density, Diagnostic Test: Perception Threshold Tracking, Diagnostic Test: Assessment of cardiovascular autonomic neuropathy, Diagnostic Test: Handgrip strength, Diagnostic Test: Force plate platform, Diagnostic Test: Biospecimen collection, Diagnostic Test: Isometric leg extension strength, Diagnostic Test: Michigan Neuropathy Screening InstrumentSubjects with T2D and no previous history of any fractures or diabetic neuropathy (n=160) |
| T2D F+ | – | Diagnostic Test: Dual Energy X-ray Absorbtiometry scan, Diagnostic Test: High-resolution peripheral quantitative computed tomography, Diagnostic Test: Microindentation, Diagnostic Test: Thermal perception thresholds, Diagnostic Test: Nerve conduction studies, Diagnostic Test: Composite Autonomic Symptom Score 31, Diagnostic Test: Perception Threshold Tracking, Diagnostic Test: Assessment of cardiovascular autonomic neuropathy, Diagnostic Test: Handgrip strength, Diagnostic Test: Force plate platform, Diagnostic Test: Biospecimen collection, Diagnostic Test: Isometric leg extension strength, Diagnostic Test: Michigan Neuropathy Screening InstrumentSubjects with T2D with a previous history of a fracture(s) (any fracture, major osteoporotic fracture (MOF) and peripheral) (n=100) |
| T2D N+ | – | Diagnostic Test: Dual Energy X-ray Absorbtiometry scan, Diagnostic Test: High-resolution peripheral quantitative computed tomography, Diagnostic Test: Microindentation, Diagnostic Test: Thermal perception thresholds, Diagnostic Test: Nerve conduction studies, Diagnostic Test: Composite Autonomic Symptom Score 31, Diagnostic Test: Skin biopsies with quantification of intra-epidermal nerve fibre density, Diagnostic Test: Perception Threshold Tracking, Diagnostic Test: Assessment of cardiovascular autonomic neuropathy, Diagnostic Test: Handgrip strength, Diagnostic Test: Force plate platform, Diagnostic Test: Biospecimen collection, Diagnostic Test: Isometric leg extension strength, Diagnostic Test: Michigan Neuropathy Screening InstrumentSubjects with T2D matched by age and sex with severe peripheral (vibration perception threshold (VPT) > 50) or a history of autonomic neuropathy (n=40) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- T2D with and without fractures and neuropathy.
Key inclusion criteria (10 listed)
- Men and women with minimum 40 years of age.
- Diagnosis of T2D. At least one of the following criteria must be met at diagnosis:
- Diagnosis of diabetes at least one year prior to inclusion of the study to avoid honeymoon diabetes.
- A history of fracture(s) (confirmed by radiographs analyzed by radiologist) following the diabetes diagnosis (T2D F+ group)
- Diagnosed with severe peripheral (VPT ≥ 50) or autonomic neuropathy defined by cardiac autonomic reflex tests or severe abnormalities in orthostatic blood pressure (T2D N+ group)
Key exclusion criteria (16 listed)
- Severe decreased liver function (Alanin amino-transaminase (ALAT) >250 U/l, Gamma-Glutamyltransferase (GGT) >150 U/l).
- Moderate to severe kidney dysfunction, estimated Glomerular Filtration Rate (eGFR) <15 mmol/L/1,73m2.
- Pregnancy or breast feeding.
- Active malignancy or terminal ill.
- Previous chemotherapy or immunomodulating treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual Energy X-ray Absorbtiometry scanAlso: DXAEvaluation of body composition and bone mass density | Diagnostic test | T2D F+, T2D F-/N-, T2D N+ |
| High-resolution peripheral quantitative computed tomographyAlso: HR-pQCTHigh-resolution peripheral quantitative computed tomography (HR-pQCT) assesses both volumetric bone mineral density (vBMD) and trabecular and cortical microarchitecture. | Diagnostic test | T2D F+, T2D F-/N-, T2D N+ |
| MicroindentationAlso: Osteoprobe, ActiveLife, Santa Barbara, CAMeasures Bone Material Strength Index (BMSi) of cortical bone. | Diagnostic test | T2D F+, T2D F-/N-, T2D N+ |
| Thermal perception thresholdsAlso: Quantitative Sensory TestingHeat and cold perception thresholds | Diagnostic test | T2D F+, T2D F-/N-, T2D N+ |
| Nerve conduction studiesAlso: NCStat-DPN-CheckNerve conduction and amplitude of sural nerve | Diagnostic test | T2D F+, T2D F-/N-, T2D N+ |
| Composite Autonomic Symptom Score 31Also: COMPASS 31A 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 | T2D F+, T2D F-/N-, T2D N+ |
| Skin biopsies with quantification of intra-epidermal nerve fibre densityAlso: PGP9.5, antibodies for subsets of ion-channels ectSkin biopsy | Diagnostic test | T2D F-/N-, T2D N+ |
| Perception Threshold TrackingAlso: PTTTranscutaneous stimulation of large and small nerve fibres using weak electrical currents | Diagnostic test | T2D F+, T2D F-/N-, T2D N+ |
| Assessment of cardiovascular autonomic neuropathyAlso: Vagus device, Medicus Engineering ApS, Aarhus, DenmarkElectrocardiographic recordings at rest and during cardiovascular autonomic reflex tests. | Diagnostic test | T2D F+, T2D F-/N-, T2D N+ |
| Handgrip strengthAlso: Hydraulic dynamometer, Saehan Corporation, Gyungnam, South KoreaEvaluation of muscle strength | Diagnostic test | T2D F+, T2D F-/N-, T2D N+ |
| Force plate platformAlso: Plux Biosignals, S.A, Arruda dos Vinhos, PortugalEvaluation of balance while standing still | Diagnostic test | T2D F+, T2D F-/N-, T2D N+ |
| Biospecimen collectionAlso: Blood samples, Urine samplesBiochemistry including bone turnover markers, glycemic status, inflammation markers i.e | Diagnostic test | T2D F+, T2D F-/N-, T2D N+ |
| Isometric leg extension strengthAlso: EasyForce Digital DynamometerEvaluation of muscle strength | Diagnostic test | T2D F+, T2D F-/N-, T2D N+ |
| Michigan Neuropathy Screening InstrumentAlso: MNSIMNSI 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. | Diagnostic test | T2D F+, T2D F-/N-, T2D N+ |
Primary outcome
Evaluation of differences in bone microarchitecture between T2D patients with and without previous fractures assessed by HRpQCT.
Time frame: Through study completion, estimated 3.5 years
Bone microarchitecture is a composite outcome assessed by HRpQCT at radius and tibia: Total volumetric mineral density, Trabecular volumetric mineral density, Cortical volumetric mineral density, Trabecular number, Trabecular thickness, Cortical thickness, Trabecular separation, Cortical porosity, bone stiffness and failure load.
Differences in Bone material strength index (BMSi) between T2D patients with and without previous fractures measured by microindentation.
Time frame: Through study completion, estimated 3.5 years
Evaluation of differences in bone turnover markers between T2D patients with and without previous fractures by biochemical analysis of different bone markers (CTX, P1NP, osteocalcin (OC), ucOC, sclerostin, osteoglycin and osteopontin).
Time frame: Through study completion, estimated 3.5 years
10 secondary outcomes
The impact of autonomic neuropathy on bone microarchitecture in T2D assessed by HR-pQCT.
Time frame: Through study completion, estimated 3.5 years
The impact of autonomic neuropathy on bone material strength in T2D assessed by microindentation.
Time frame: Through study completion, estimated 3.5 years
The impact of autonomic neuropathy on bone turnover markers in T2D.
Time frame: Through study completion, estimated 3.5 years
The impact of peripheral neuropathy on bone microarchitecture in T2D assessed by HR-pQCT.
Time frame: Through study completion, estimated 3.5 years
The impact of peripheral neuropathy on bone material strength in T2D assessed by microindentation.
Time frame: Through study completion, estimated 3.5 years
The impact of peripheral neuropathy on bone turnover markers in T2D.
Time frame: Through study completion, estimated 3.5 years
Compare postural control between T2D patients with and without fractures assessed by force platform.
Time frame: Through study completion, estimated 3.5 years
Compare postural control between T2D patients with and without peripheral/autonomic neuropathy.
Time frame: Through study completion, estimated 3.5 years
Compare muscle mass and strength in T2D patients with and without fractures
Time frame: Through study completion, estimated 3.5 years
Compare muscle mass and strength in T2D patients with and without neuropathy
Time frame: Through study completion, estimated 3.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: Undecided. Potential analysis of skin biopsies in external lab
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Bone Disease, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Lindgård Graversen, MD (97663651 ext. +45, j.lindgaard@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of differences in bone microarchitecture between T2D patients with and without previous fractures assessed by HRpQCT. (time frame: Through study completion, estimated 3.5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.