NCT06902597

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

March 30, 2025

Status Verified

January 1, 2025

Enrollment Period

12 months

First QC Date

January 31, 2025

Last Update Submit

March 27, 2025

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Prevalence of sarcopenia

    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

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • Prevalence of microvascular complications in subjects with T1DM and sarcopenia

    through study completion, an average of 1 year

  • Prevalence of dynapenia

    through study completion, an average of 1 year

Study Arms (1)

Type 1 Diabetes

EXPERIMENTAL

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

Procedure: Dual energy X-ray absorptiometry

Interventions

Dual energy X-ray absorptiometryPROCEDURE

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

Also known as: DEXA (Dual X-ray Absorptiometry)
Type 1 Diabetes

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC Diabetologia

Rome, Lazio, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Dario Pitocco

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dario Pitocco

CONTACT

+39 0630154071dario.pitocco@policlinicogemelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2025

First Posted

March 30, 2025

Study Start

February 1, 2025

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

March 30, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)