NCT06902597Recruiting
Association Between Sarcopenia And Diabetic Neuropathy In Adults With Type 1 Diabetes, A Pilot Study
Source: ClinicalTrials.gov · Last updated 30 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 31 Jan 2025
- Start date
- 1 Feb 2025
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Type 1 diabetes
- NCT number
- NCT06902597
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 1 Feb 2025 to the primary completion date, 31 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous diagnosis of T2DM
- Previous diagnosis of dementia
- Previous history of stroke or cerebrovascular disease
- Untreated hypothyroidism or hyperthyroidism or not well controlled hypothyroidism or hyperthyroidism with current therapy (TSH \>5 or TSH \<0.15)
- 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
Other illness
- Presence of heart failure (NYHA class III and IV)
- Presence of muscular disease
- Diagnosis of neurodegenerative disease (e.g. multiple sclerosis, Parkinson's disease)
- Diagnosis of coeliac disease
- Diagnosis of chronic inflammatory bowel disease
- Active cancer or therapy
Lab values
- eGFR evaluated through CKD-EPI formula \<20 ml/min /1.73m2 , estimated on previous creatinine dosage
Other
- Alcohol abuse or consumption of more than 14 alcoholic units weekly
- Pregnancy
- Primary hyperparathyroidism
Who the study is looking for
- 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
Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC Diabetologia Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.