Link between muscle loss and nerve damage in adults with type 1 diabetes
Association Between Sarcopenia And Diabetic Neuropathy In Adults With Type 1 Diabetes, A Pilot Study
This study is testing how muscle loss and nerve damage are related in adults aged 50-80 with type 1 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, Lazio) |
| Trial ID | NCT06902597 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50-80 with a diagnosis of type 1 diabetes for at least 10 years.
Not a fit: Patients with type 2 diabetes or significant comorbidities such as heart failure or neurodegenerative diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of muscle loss and nerve damage in patients with type 1 diabetes.
How similar studies have performed: While the association between sarcopenia and diabetic neuropathy is a relatively novel area of investigation, similar studies have indicated potential links between muscle health and diabetes complications.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rome, Lazio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.