Status:
RECRUITING
Association Between Sarcopenia And Diabetic Neuropathy In Adults With Type 1 Diabetes, A Pilot Study
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
50-80 years
Phase:
NA
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 i...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06902597
Start Date
February 1 2025
End Date
January 31 2026
Last Update
March 30 2025
Active Locations (1)
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1
Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC Diabetologia
Rome, Lazio, Italy, 00168