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Official title Association Between Sarcopenia And Diabetic Neuropathy In Adults With Type 1 Diabetes, A Pilot Study
ClinicalTrials.gov ID: NCT06902597
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80
You may be able to join 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 likely can't join 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Lazio, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Lazio, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.