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NCT Number: NCT06902597

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

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC Diabetologia

Rome, Lazio, 00168, Italy

Location status: Recruiting

Location contact

Dario Pitocco

PRINCIPAL_INVESTIGATOR

Dario Pitocco, Prof

CONTACT

[email protected]

+390630155701

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dual energy X-ray absorptiometry

Procedure

Very low radiation dose technique to show fat mass (FM) and lean mass (LM)

Other names: DEXA (Dual X-ray Absorptiometry)

Primary outcomes

  1. Prevalence of sarcopenia

    Time frame: 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 outcomes

  1. Prevalence of microvascular complications in subjects with T1DM and sarcopenia

    Time frame: 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

  2. Prevalence of dynapenia

    Time frame: through study completion, an average of 1 year

    Prevalence of dynapenia

Study contacts

Contact information is provided by the study sponsor or research team.

Dario Pitocco

CONTACT

[email protected]

+39 0630154071

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: SARCO_DM1

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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