Association Between Sarcopenia And Diabetic Neuropathy In Adults With Type 1 Diabetes, A Pilot Study (SARCO_DM1)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Type 1 Diabetes

Treatments: Procedure: Dual energy X-ray absorptiometry

Study type: Interventional

Funder types: Other

Identifiers

NCT06902597

7119

Details and patient eligibility

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Type 1 Diabetes

Experimental group

Description:

Subjects with type 1 diabetes who will be evaluated for sarcopenia, evaluating body composition through DEXA and muscular strength by handgrip.

Treatment:

Procedure: Dual energy X-ray absorptiometry