Link between muscle loss and nerve damage in adults with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to evaluate the prevalence of sarcopenia, which is the loss of muscle mass, in adults aged 50-80 with type 1 diabetes. It will also investigate the association between diabetic neuropathy, a common complication of diabetes, and sarcopenia in this population. Participants will undergo dual energy X-ray absorptiometry to assess their muscle mass and strength. The study seeks to provide insights into how these two conditions may be interconnected in individuals with long-standing type 1 diabetes.

Why it matters

Who can join: the full rules

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

Where it's running

• Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC Diabetologia
  Rome, Lazio, Italy Recruiting

Study contacts

• Principal investigator: Dario Pitocco — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Dario Pitocco
• Email: dario.pitocco@policlinicogemelli.it
• Phone: +39 0630154071

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.