Deep Phenotyping of Bone Disease in Type 2 Diabetes and Relations to Diabetic Neuropathy

Launched by AALBORG UNIVERSITY HOSPITAL · Nov 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how bone health is affected in people with type 2 diabetes (T2D), especially in relation to conditions like diabetic neuropathy, which can impact nerve function. Researchers want to understand differences in bone structure and strength between T2D patients who have had fractures and those who haven’t. They will also explore how nerve problems influence bone health and balance. The trial involves various tests, including blood samples, bone scans, and assessments of nerve and muscle function.

To participate, you need to be at least 40 years old and have a diagnosis of type 2 diabetes for at least a year. There are specific groups for those with no history of fractures, those with past fractures, and those with severe nerve issues. If eligible, participants will undergo several examinations to help researchers gather important information about bone health in T2D patients. It’s a great opportunity to contribute to understanding how diabetes affects bone disease, which could help improve treatment in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Men and women with minimum 40 years of age.
• 2. Diagnosis of T2D. At least one of the following criteria must be met at diagnosis:
• • 1. HbA1c ≥ 48 mmol/mol (6,5 %)
• • 2. Plasma glucose ≥ 11,1 mmol/l
• • 3. Fasting plasma glucose ≥7,0 mmol/l Clinical effect of oral antidiabetic medication strengthens the diagnosis.
• • 3. Diagnosis of diabetes at least one year prior to inclusion of the study to avoid honeymoon diabetes.
• • 4. A history of fracture(s) (confirmed by radiographs analyzed by radiologist) following the diabetes diagnosis (T2D F+ group)
• • 5. 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)
• • 6. Signed the informed consent.
• • 7. Not defined by the exclusion criteria.
• Exclusion Criteria:
• • 1. Severe decreased liver function (Alanin amino-transaminase (ALAT) \>250 U/l, Gamma-Glutamyltransferase (GGT) \>150 U/l).
• • 2. Moderate to severe kidney dysfunction, estimated Glomerular Filtration Rate (eGFR) \<15 mmol/L/1,73m2.
• • 3. Pregnancy or breast feeding.
• • 4. Active malignancy or terminal ill.
• • 5. Previous chemotherapy or immunomodulating treatment
• • 6. Known severe vitamin deficiency
• • 7. Current or previous alcohol- or drug abuse.
• • 8. Not being able to understand Danish written and/or verbally.
• • 9. Terms according to investigators judgement that makes subjects unsuitable to participate including lack of ability to understand and comply with instructions and/or reduced physical ability, limiting the ability to participate in the examinations.
• • 10. Participating in other clinical studies utilizing experimental treatment or medication.
• • 11. Subjects with pathologic fractures (defined as fractures due to local tumors, tumor-like lesions, or focal demineralization as visualized on radiographs).
• • 12. Primary hyperparathyroidism, Paget's disease and other metabolic bone diseases, uncontrolled thyrotoxicosis, celiac disease not controlled by diet, known hypogonadism, severe COPD, hypopituitarism, Cushing's disease.
• • 13. Fracture \< 6 month ago
• • 14. Initiation of antiresorptive or bone anabolic drugs \<12 months ago to ensure stable bone turnover markers.
• • 15. History of fractures following the diagnosis of diabetes (T2D F-/N- and T2D N+ groups).
• • 16. History of peripheral or autonomic neuropathy defined by cardiac autonomic reflex tests or severe abnormalities in orthostatic blood pressure (T2D F-/N- group).