NCT06902597 Association Between Sarcopenia And Diabetic Neuropathy In Adults With Type 1 Diabetes, A Pilot Study
| NCT ID | NCT06902597 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-02-01 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Dario Pitocco
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06902597 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06902597 currently recruiting?
Yes, NCT06902597 is actively recruiting participants. Contact the research team at dario.pitocco@policlinicogemelli.it for enrollment information.
Where is the NCT06902597 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06902597 clinical trial?
NCT06902597 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Dario Pitocco at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 150 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.