Association Between Sarcopenia And Diabetic Neuropathy In Adults With Type 1 Diabetes, A Pilot Study

Not Applicable

Recruiting

• Conditions: Type 1 Diabetes

• Registration Number: NCT06902597
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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 in subjects with T1DM; to evaluate the prevalence of dynapenia in adults with T1DM and its association with diabetic neuropathy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-31
• Study Start: 2025-02-01
• Study First Submitted QC: 2025-03-27
• Last Update Submitted: 2025-03-27
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Prevalence of sarcopenia	through study completion, an average of 1 year	Prevalence of sarcopenia in adult population with T1DM. Sarcopenia will be defined according to the 2018 European Working Group on Sarcopenia in Older People (EWGSOP) guidelines

Secondary Outcome Measures

Name	Time	Method
Prevalence of microvascular complications in subjects with T1DM and sarcopenia	through study completion, an average of 1 year	Prevalence of peripheral diabetic neuropathy, autonomic diabetic neuropathy, diabetic retinopathy, diabetic nephropathy in subjects with T1DM and sarcopenia
Prevalence of dynapenia	through study completion, an average of 1 year	Prevalence of dynapenia

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC Diabetologia; 🇮🇹 Roma, Lazio, Italy