Menu
Recruiting NCT06902597

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

No phase Interventional Type 1 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dual energy X-ray absorptiometry.
Who it may be relevant to
Registry conditions: Type 1 Diabetes. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure Dual energy X-ray absorptiometry
    Very low radiation dose technique to show fat mass (FM) and lean mass (LM)

Primary outcome measures

  • Prevalence of sarcopenia [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (2)
  • Prevalence of microvascular complications in subjects with T1DM and sarcopenia [Time frame: through study completion, an average of 1 year]
  • Prevalence of dynapenia [Time frame: through study completion, an average of 1 year]

Eligibility criteria

Inclusion 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

Italy · 1 center
  • Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC Diabetologia — Rome

Identifiers

NCT: NCT06902597 · 7119

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗