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Type 1 Diabetes MellitusBOLD-1NCT03751839

Microarchitecture, Bone Strength and Fracture Risk in Long-term Type 1 Diabetes

A study testing Biochemical Tests, Osteodensitometry and Clinical Tests in people with Type 1 Diabetes Mellitus, run by Christian Meier at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This single center case control study will assess differences in bone structure between women and men with longstanding type 1 diabetes (diabetes duration>/= 25 years) and healthy controls. Read more about this study

Who is it for?
Ages 40 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Biochemical Tests, Osteodensitometry and Clinical Tests
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteSwitzerland
Study dates
1 Oct 2018to 1 Jul 2021
Phase
Interventional
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 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • women and men with longstanding type 1 diabetes (age 40-80 years, BMI 18-37 kg/m2 and age- and sex matched non-diabetic controls
  • presence of type 1 diabetes for at least 25 years (defined by history of Insulin treatment)

Who cannot join

  • Patients unable to give written informed consent, e.g. with severe dementia or patients not understanding German (or other local language)
  • Any medical or psychiatric condition which would preclude the participant from adhering to the protocol
  • Idiopathic or premenopausal osteoporosis or coexisting metabolic bone disease (e.g. Paget´s disease, primary hyperparathyroidism)
  • Previous treatment with osteoporosis medication (bisphosphonates, denosumab) or intake of medications that are known to affect bone metabolism (e.g. steroids, anticonvulsants) within 6 months prior to enrollment
  • Patients with medical conditions known to affect bone health ( e.g. metastatic bone disease, celiac disease, inflammatory bone disease, hypogonadism, thyrotoxicosis, hypercortisolism, chronic kidney disease stage IV and V (KDIGO), liver dysfunction (serum aspartate amino transferase (ASAT) >3 times the upper limit of normal)
  • Inability to keep the extremities still for a few minutes of an HR-pQCT examination (e.g. Parkinson disease, spastic syndrome)
  • Pregnant or breastfeeding women

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel

    Basel, Canton of Basel-City, 4031

Other trials in Switzerland

About this study

This single center case control study will assess differences in bone structure between women and men with longstanding type 1 diabetes (diabetes duration>/= 25 years) and healthy controls.

Read the detailed description

Based on a cross-sectional approach the investigators aim to assess microstructural, biomechanical and densitometric bone characteristics in patients with longstanding type 1 diabetes and age- and sex-matches controls. The investigators examine whether the presence of microvascular disease and/or poor diabetic control is associated with an altered bone microarchitecture and whether any such effect is independent of bone mineral density. Furthermore, the investigators aim to look into the relationship between an altered bone microarchitecture and advanced glycation end product (AGE) formation as well as biochemical markers of bone formation and bone turnover. The study aims to identify type 1 diabetic patients with high fracture risk by assessing the discriminatory power of parameters of cortical and trabecular microstructure measured via high resolution peripheral quantitative computed tomography (HR-pQCT) of the distal radius and tibia and high resolution quantitative computed tomography (HR-QCT) of the proximal femur and tibia with and without adjustment for bone density.

Being tested
Biochemical Tests, Osteodensitometry, Clinical Tests, HR-QCT, HR-pQCT
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biochemical TestsDiagnostic test

    The investigators will perform blood tests in every participant.

  • OsteodensitometryDiagnostic test

    Also called dual energy x-ray absorptiometry (DXA scan)

    The investigators will perform an osteodensitometry in every participant.

  • Clinical TestsDiagnostic test

    The investigators perform the following clinical tests: vibration threshold test, monofilament test, chair rise test and timed up and go test in every participant.

  • HR-QCTDiagnostic test

    The investigators will perform HR-QCT measurements of the proximal femur and tibia in every participant.

  • HR-pQCTDiagnostic test

    The investigators will perform HR-pQCT measurements of the distal radius and distal tibia in every participant.

Study groups in NCT03751839
Study groupRoleWhat they receive
DiagnosticExperimentalThe investigators will examine all participants in the same way by performing biochemical tests, clinical tests, osteodensitometry, HRQCT and HRpQCT measurements.
Receives: Diagnostic Test: Biochemical Tests; Diagnostic Test: Osteodensitometry; Diagnostic Test: Clinical Tests; Diagnostic Test: HR-QCT; Diagnostic Test: HR-pQCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. volumetric bone mineral density in mg hydroxyapatite (HA)/ccm

    measured by HR-pQCT at the distal radius and tibia

    Measured: through study completion, an average of 6 months

  2. cortical porosity in %

    measured by HR-pQCT at the distal radius and tibia

    Measured: through study completion, an average of 6 months

  3. bone stiffness in kilonewton (kN)/mm

    a measure of bone strength, measured by HR-pQCT at the distal radius and tibia

    Measured: through study completion, an average of 6 months

  4. failure load in kN

    a measure of bone strength, measured by HR-pQCT at the distal radius and tibia

    Measured: through study completion, an average of 6 months

Secondary outcomes (18)

  1. areal bone mineral density of the spine in g/cm2

    measured by osteodensitometry (DXA)

    Measured: through study completion, an average of 6 months

  2. areal bone mineral density of the proximal femur in g/cm2

    measured by osteodensitometry

    Measured: through study completion, an average of 6 months

  3. areal bone mineral density of the distal radius in g/cm2

    measured by osteodensitometry

    Measured: through study completion, an average of 6 months

  4. trabecular bone score of the spine

    a measure of bone texture, measured by osteodensitometry

    Measured: through study completion, an average of 6 months

  5. cortical thickness at the mid tibia in cm

    the cortical thickness will be measured by pulse-echo ultrasound and high resolution quantitative computed tomography (HR-QCT)

    Measured: through study completion, an average of 6 months

  6. density weighed cortical thickness at the mid tibia in cm

    the density weighed cortical thickness will be measured by pulse-echo ultrasound and HR- QCT

    Measured: through study completion, an average of 6 months

  7. bone marrow adiposity in mg/cm3

    measured by HR-pQCT

    Measured: through study completion, an average of 6 months

  8. measurement of serum carboxy-terminal collagen crosslinks (CTX) in pg/ml

    biochemical marker of bone resorption

    Measured: through study completion, an average of 6 months

  9. measurement of serum n-terminal procollagen type 1 (P1NP) in mcg/l

    biochemical marker of bone formation

    Measured: through study completion, an average of 6 months

  10. measurement of serum pentosidine in pmol/m

    biochemical marker associated with bone fragility

    Measured: through study completion, an average of 6 months

  11. measurement of serum carboxymethyl-lysine (CML) in pmol/ml

    biochemical marker associated with bone fragility

    Measured: through study completion, an average of 6 months

  12. measurement of serum insulin in mU/ml

    biochemical marker associated with bone fragility

    Measured: through study completion, an average of 6 months

  13. measurement of serum sclerostin in pg/ml

    biochemical marker associated with bone fragility

    Measured: through study completion, an average of 6 months

  14. measurement of serum adiponectin in ng/ml

    biochemical marker associated with bone fragility

    Measured: through study completion, an average of 6 months

  15. measurement of serum insulin like growth factor -1 (IGF1) in nM

    biochemical marker associated with bone fragility

    Measured: through study completion, an average of 6 months

  16. measurement of serum ultrasensitive c-reactive protein (usCRP) in mg/l

    biochemical marker associated with bone fragility

    Measured: through study completion, an average of 6 months

  17. measurement of serum interleukin 6 (IL6) in pg/ml

    biochemical marker associated with bone fragility

    Measured: through study completion, an average of 6 months

  18. measurement of serum periostin in ng/ml

    biochemical marker associated with bone fragility

    Measured: through study completion, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2018
  2. Study start1 Oct 2018
  3. Primary completion1 Jul 2021
  4. Study completion1 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Identical diagnostic procedures will be performed in participants with type 1 diabetes and age- and sex-matched controls.
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03751839
Sponsor's protocol ID
EKNZ 2018-01517
Acronym
BOLD-1
Status last verified
Jul 2021
First submitted
31 Oct 2018
Last updated
27 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: In the informed consent document participants can choose whether they agree to the further use of their coded data and biochemical material for future research purposes.

Questions about this trial

What is this clinical trial studying?

A study testing Biochemical Tests, Osteodensitometry and Clinical Tests in people with Type 1 Diabetes Mellitus, run by Christian Meier at 1 site in Switzerland.

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 2 inclusion and 7 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: finished, as of the sponsor's last update on 27 Jul 2021. 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 Switzerland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

volumetric bone mineral density in mg hydroxyapatite (HA)/ccm (time frame: through study completion, an average of 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03751839.

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 27 Jul 2021.

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BOLD-1 Clinical Trial NCT03751839 | AzTrials