the Type ONe dIabetic Bone Collaboration Study

Summary

In this cross-sectional clinical study, we will examine the bones of 111 Type 1 Diabetes (T1D) patients and 37 age-matched healthy controls with the aim of describing a T1D Bone Phenotype. The main Objectives of the study is a) to determine if the material properties of the bones are affected in diabetic bone disease and b) to determine if the mitochondrial function in osteoclasts and osteoblasts is impaired in T1D. Secondary end points are c) to establishment of the T1D bone phenotype and d) to investigate if mitochondrial dysfunction in T1D bone cells correlates to changes in gene expression, gene activity, bone remodelling, bone density, microarchitecture, geometry and material properties. Furthermore, in terms of contributing to knowledge on etiology and pathology of type one diabetic bone disease, we will study the predictory value of muscle mass in T1D patients and controls, as well as other characteristics such as heart rate variability (HRV) and AGE content. Furthermore, we will study the epidemiology of osteoporosis and fractures in Danish T1D patients.

To assess the material properties of the bones, we will measure the bone mass density (BMD), use High Resolution peripheral Quantitative Computed Tomography (HRpQCT) for assessment of the microarchitecture and finite element analysis of bone strength, and by microindentation, we will obtain direct measures of the strength of the cortical bone of the tibia. Further we will measure bone turnover markers and circulating microRNA and in a subgroup of participants (24 T1D, 12 controls) bone samples will be retrieved for examination of bone histomorphometry (structural and static parameters) and cell samples from blood and bone marrow will be used for in vitro experiments focused on cell differentiation mitochondrial function, as hyperglycemia may affect mitochondrial function. Finally measures of some possible predictors of bone fragility in subjects with T1D are examined (sarcopenia, skin advanced glycation end products (AGE) content, autonomic neuropathy)

Conditions

• Osteoporosis Secondary
• Diabetes Mellitus, Type 1

Sponsors & Collaborators

• Aalborg University Hospital

  collaborator OTHER

• Steno Diabetes Center Nordjylland

  collaborator OTHER

• Esbjerg Hospital - University Hospital of Southern Denmark

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Steno Diabetes Center Odense

  collaborator OTHER

• Molecular endocrinology department (KMEB)

  collaborator UNKNOWN

• Odense University Hospital

  lead OTHER

Principal Investigators

• Morten F Nielsen, MD PhD Prof. · Odense University Hospital

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-12-10

Primary Completion

2024-04-01

Completion

2024-04-01

Countries

• Denmark

Study Locations