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Association Between Sarcopenia And Diabetic Neuropathy In Adults With Type 1 Diabetes, A Pilot Study

NCT06902597 · Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 150 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-02-01
Estimated completion: 2026-01-31
Last updated: 2025-03-30
Interventions
Procedure: Dual energy X-ray absorptiometry
Primary outcomes
  • Prevalence of sarcopenia (through study completion, an average of 1 year)
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · other
Contacts & investigators
ContactDario Pitocco · contact · dario.pitocco@policlinicogemelli.it · +39 0630154071
InvestigatorDario Pitocco · principal_investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
All locations (1)
Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC DiabetologiaRecruiting
Rome, Lazio, Italy
Association Between Sarcopenia And Diabetic Neuropathy In Adults With Type 1 Diabetes, A Pilot Study · TrialPath