Type 1 Diabetes
Conditions
Brief summary
Monocentric interventional prospective study to evaluate the prevalence of sarcopenia in adults with type 1 diabetes (T1DM) and to evaluate the association between diabetic neuropathy and sarcopenia in subjects with T1DM; to evaluate the prevalence of dynapenia in adults with T1DM and its association with diabetic neuropathy.
Interventions
PROCEDUREDual energy X-ray absorptiometry
Very low radiation dose technique to show fat mass (FM) and lean mass (LM)
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 50-80 years, both sexes 2. Diagnosis of T1DM for at least 10 years, in both multiple daily injections of insulin (MDI) and continuous subcutaneous insulin infusion (CSII) 3. Informed consent before any study activity 4. Ability to fully perform all protocol activities
Exclusion criteria
1. Previous diagnosis of T2DM 2. Previous diagnosis of dementia 3. Presence of heart failure (NYHA class III and IV) 4. Presence of muscular disease 5. Diagnosis of neurodegenerative disease (e.g. multiple sclerosis, Parkinson's disease) 6. eGFR evaluated through CKD-EPI formula \<20 ml/min /1.73m2 , estimated on previous creatinine dosage 7. Previous history of stroke or cerebrovascular disease 8. Diagnosis of coeliac disease 9. Diagnosis of chronic inflammatory bowel disease 10. Untreated hypothyroidism or hyperthyroidism or not well controlled hypothyroidism or hyperthyroidism with current therapy (TSH \>5 or TSH \<0.15) 11. Alcohol abuse or consumption of more than 14 alcoholic units weekly 12. Active cancer or therapy 13. Pregnancy 14. Primary hyperparathyroidism 15. Corticosteroid and/or estrogen-progestogen therapy for at least 12 months in medical history 16. On going treatment with antiretroviral therapy 17. On going treatment with immunosuppressive therapy, e.g. cyclosporine, tacrolimus 18. On going treatment with anti-epileptic drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of sarcopenia | through study completion, an average of 1 year | Prevalence of sarcopenia in adult population with T1DM. Sarcopenia will be defined according to the 2018 European Working Group on Sarcopenia in Older People (EWGSOP) guidelines |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of microvascular complications in subjects with T1DM and sarcopenia | through study completion, an average of 1 year | Prevalence of peripheral diabetic neuropathy, autonomic diabetic neuropathy, diabetic retinopathy, diabetic nephropathy in subjects with T1DM and sarcopenia |
| Prevalence of dynapenia | through study completion, an average of 1 year | Prevalence of dynapenia |
Countries
Italy
Contacts
Primary ContactDario Pitocco
Outcome results
None listed