An evaluation of bone microarchitecture in type 1 diabetes v1.0
Research type
Research Study
Full title
A cross-sectional observational study of bone microarchitecture in type 1 diabetes patients with neuropathy in South Yorkshire, UK and its comparison with type 1 diabetes without neuropathy and healthy controls. \n
IRAS ID
222726
Contact name
Tatiane Vilaca
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 3 months, 28 days
Research summary
Is there an impact of type 1 diabetes on bone microstructure and is this influenced by the presence of nerve damage?\nPatients with type 1 diabetes have a greater risk of hip fracture (breaking hip bone) than people without the disease. We do not know why it happens, but it seems to be more important in patients with diabetic complications, like nerve damage. To understand why people with diabetes have a higher risk of breaking bones we will evaluate bone health in people with and without the disease. To understand if the presence of nerve damage is an important feature, we will evaluate patients with and without nerve damage. The metabolic control, muscle strength, walking and balance (which can influence the risk of falling and consequently breaking bones) might also be important and they will be evaluated. A better understanding of bone health in diabetes could help patients and healthcare professionals to take adequate measures to prevent fractures in this population.\nThe aim of the study is to look for differences in bone health in adult patients with diabetes with and without nerve damage and healthy controls. This information will help us to understand why people with diabetes break more bones. Participants with diabetes will undergo a nerve evaluation to establish if they do or do not have nerve damage. We will perform blood tests, bone scans, physical tests (simple tasks like, sitting, standing and walking)and a skin light reflection test in the patients with diabetes and in healthy controls. Participants with diabetes will have their medical history reviewed, to look for correlations between diabetic metabolic control and bone health parameters. \nParticipants will be recruited from potential volunteers list (people who have participated on previous studies and agreed to be contacted again) and from diabetes clinics. This research is funded by Amgen.\n
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0291
Date of REC Opinion
5 Jun 2017
REC opinion
Further Information Favourable Opinion