An observational study in Type 2 Diabetes, Bone Disease and Osteoporosis, sponsored by Aalborg University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by Aalborg University Hospital · Observational
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:
Methods:
The trial is of cross-sectional design and consists of examinations including
Participants:
A total of 300 type 2 diabetes patients divided to three groups:
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 300 is close to the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Aalborg University Hospital is the lead sponsor of 198 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
T2D with and without fractures and neuropathy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of T2D. At least one of the following criteria must be met at diagnosis:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with T2D and no previous history of any fractures or diabetic neuropathy (n=160)
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
Subjects with T2D with a previous history of a fracture(s) (any fracture, major osteoporotic fracture (MOF) and peripheral) (n=100)
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
Subjects with T2D matched by age and sex with severe peripheral (vibration perception threshold (VPT) \> 50) or a history of autonomic neuropathy (n=40)
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
Evaluation of body composition and bone mass density
Also known as: DXA
High-resolution peripheral quantitative computed tomography (HR-pQCT) assesses both volumetric bone mineral density (vBMD) and trabecular and cortical microarchitecture.
Also known as: HR-pQCT
Measures Bone Material Strength Index (BMSi) of cortical bone.
Also known as: Osteoprobe, ActiveLife, Santa Barbara, CA
Heat and cold perception thresholds
Also known as: Quantitative Sensory Testing
Nerve conduction and amplitude of sural nerve
Also known as: NCStat-DPN-Check
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
Also known as: COMPASS 31
Skin biopsy
Also known as: PGP9.5, antibodies for subsets of ion-channels ect
Transcutaneous stimulation of large and small nerve fibres using weak electrical currents
Also known as: PTT
Electrocardiographic recordings at rest and during cardiovascular autonomic reflex tests.
Also known as: Vagus device, Medicus Engineering ApS, Aarhus, Denmark
Evaluation of muscle strength
Also known as: Hydraulic dynamometer, Saehan Corporation, Gyungnam, South Korea
Evaluation of balance while standing still
Also known as: Plux Biosignals, S.A, Arruda dos Vinhos, Portugal
Biochemistry including bone turnover markers, glycemic status, inflammation markers i.e
Also known as: Blood samples, Urine samples
Evaluation of muscle strength
Also known as: EasyForce Digital Dynamometer
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.
Also known as: MNSI
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.
Time frame: 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.
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
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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
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.
Neuropathy assessed by PTT, QST, sural nerve conduction study, skin biopsies, COMPASS-31, MNSI and Vagus device. Postural control assessed by force platform.
Time frame: 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.
Time frame: 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).
Time frame: Through study completion, estimated 3.5 years
Co-existence of peripheral and autonomic neuropathy
Presence of autonomic neuropathy (assessed by CAN-score from Vagus™ device, COMPASS31-score, intraepidermal nerve fiber density, orthostatic BP and ECG) will be compared with presence of peripheral neuropathy (assessed by PTT, QST, sural nerve conduction test and intraepidermal nerve fiber density) in T2D.
Time frame: Through study completion, estimated 3.5 years
The impact of insulin resistance (assessed by HOMA-IR and -%B) on bone microarchitecture (assessed by HR-pQCT) in T2D.
Time frame: Through study completion, estimated 3.5 years
The impact of insulin resistance (assessed by HOMA-IR and -%B) on bone material strength (assessed by microindentation) in T2D.
Time frame: Through study completion, estimated 3.5 years
The impact of insulin resistance (assessed by HOMA-IR and -%B) on bone turnover markers in T2D.
Time frame: Through study completion, estimated 3.5 years
The correlation between levels of Advanced Glycation End Products (AGEs) (assessed by skin autofluorescence) and bone material strength (assessed by microindentation).
Time frame: Through study completion, estimated 3.5 years
Plan to share: Undecided — Potential analysis of skin biopsies in external lab
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.