Actively Recruiting
Association Between Sarcopenia And Diabetic Neuropathy In Adults With Type 1 Diabetes, A Pilot Study
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-30
150
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Association Between Sarcopenia And Diabetic Neuropathy In Adults With Type 1 Diabetes, A Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 to 80 years, any gender
- Diagnosed with type 1 diabetes for at least 10 years, treated by multiple daily insulin injections or continuous subcutaneous insulin infusion
- Provided informed consent before starting any study procedures
- Able to fully complete all study activities and protocol requirements
You will not qualify if you...
- Previous diagnosis of type 2 diabetes
- Diagnosis of dementia
- Presence of severe heart failure (NYHA class III or IV)
- Presence of muscular diseases
- Diagnosis of neurodegenerative diseases such as multiple sclerosis or Parkinson's disease
- Estimated glomerular filtration rate (eGFR) less than 20 ml/min/1.73m2
- History of stroke or cerebrovascular disease
- Diagnosis of coeliac disease
- Diagnosis of chronic inflammatory bowel disease
- Untreated or poorly controlled thyroid disorders (TSH >5 or <0.15)
- Alcohol abuse or consumption exceeding 14 alcoholic units per week
- Active cancer or undergoing cancer therapy
- Pregnancy
- Primary hyperparathyroidism
- History of corticosteroid or estrogen-progestogen therapy for at least 12 months
- Current treatment with antiretroviral therapy
- Current treatment with immunosuppressive drugs such as cyclosporine or tacrolimus
- Current treatment with anti-epileptic medications
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC Diabetologia
Rome, Lazio, Italy, 00168
Actively Recruiting
Research Team
D
Dario Pitocco
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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