Deep Phenotyping of Bone Disease in Type 2 Diabetes and Relations to Diabetic Neuropathy (NCT05642143) | Clinical Trial Compass
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Deep Phenotyping of Bone Disease in Type 2 Diabetes and Relations to Diabetic Neuropathy
Denmark300 participantsStarted 2023-02-24
Plain-language 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
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. A history of fracture(s) (confirmed by radiographs analyzed by radiologist) following the diabetes diagnosis (T2D F+ group)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of differences in bone microarchitecture between T2D patients with and without previous fractures assessed by HRpQCT.
Timeframe: Through study completion, estimated 3.5 years
2
Differences in Bone material strength index (BMSi) between T2D patients with and without previous fractures measured by microindentation.
Timeframe: Through study completion, estimated 3.5 years
3
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).
Timeframe: Through study completion, estimated 3.5 years
. 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)
Exclusion criteria
. 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
. Current or previous alcohol- or drug abuse.
. Not being able to understand Danish written and/or verbally.