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

Recruiting now · Not applicable

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT06902597

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

150

Starts

2025-02-01

Expected to finish

2026-01-31

Last updated by the study team

2025-03-30

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 50-80 years, both sexes
• Diagnosis of T1DM for at least 10 years, in both multiple daily injections of insulin (MDI) and continuous subcutaneous insulin infusion (CSII)
• Informed consent before any study activity
• Ability to fully perform all protocol activities

You may not qualify if…

• Previous diagnosis of T2DM
• Previous diagnosis of dementia
• Presence of heart failure (NYHA class III and IV)
• Presence of muscular disease
• Diagnosis of neurodegenerative disease (e.g. multiple sclerosis, Parkinson's disease)
• eGFR evaluated through CKD-EPI formula <20 ml/min /1.73m2 , estimated on previous creatinine dosage
• Previous history of stroke or cerebrovascular disease
• Diagnosis of coeliac disease
• Diagnosis of chronic inflammatory bowel disease
• Untreated hypothyroidism or hyperthyroidism or not well controlled hypothyroidism or hyperthyroidism with current therapy (TSH >5 or TSH <0.15)
• Alcohol abuse or consumption of more than 14 alcoholic units weekly
• Active cancer or therapy
• Pregnancy
• Primary hyperparathyroidism
• Corticosteroid and/or estrogen-progestogen therapy for at least 12 months in medical history
• On going treatment with antiretroviral therapy
• On going treatment with immunosuppressive therapy, e.g. cyclosporine, tacrolimus
• On going treatment with anti-epileptic drugs

Where it is running

• Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC Diabetologia — Rome, Lazio, Italy (enrolling)

Full record on ClinicalTrials.gov

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