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Recruiting Not applicable

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

NCT06902597 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-02-01
Last updated
2025-03-30

Condition(s) studied

Type 1 Diabetes

Investigational drug(s) / intervention(s)

Dual energy X-ray absorptiometry

Dual energy X-ray absorptiometry: Very low radiation dose technique to show fat mass (FM) and lean mass (LM)

Study 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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC Diabetologia Rome Lazio Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06902597 on ClinicalTrials.gov ↗ ← All trials in Italy