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

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

Recruiting
50-80 years
All
Phase N/A

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Overview

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

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 details
    Type 1 Diabetes

NCT06902597

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

15 October 2025

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