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CompletedNCT02426073Updated Apr 19, 2023

Glucose Metabolism, Muscle Mass/Function and Inflammation in the Elderly

An observational study in Sarcopenia and Diabetes Mellitus, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed at 2 sites in Italy. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-19.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
76
Ages
70 Years and older
Sex
All
01

Study summary

A thorough characterization of glucose metabolism and "inflammaging" in elderly subjects will help determine to what extent each of these factors affects muscle mass/function and contributes to age-related muscle wasting. The investigators will correlate patterns of insulin secretion/sensitivity with "muscle "quality/quantity" in diabetic and non-diabetic elderlies (≥70 years old). By comparing different groups (healthy, sarcopenic, diabetic, diabetic/sarcopenic), the investigators expect to identify an "oxidative/inflammatory signature" (e.g., circulating interleukins/myokines, plasma antioxidant capacity) specific for the sarcopenic phenotype and related to muscle insulin resistance.

02

Conditions studied

  • Sarcopenia
  • Diabetes Mellitus

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Keywords

  • Inflammaging
03

In context

Sarcopenia

1,206 studies on the registry are indexed under Sarcopenia; 401 are open to participants now.

This study's enrollment of 76 is below the median of 120 across 419 observational studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Elderly (≥ 70 years) subjects

Eligibility criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus: patients taking drugs for diabetes will be diagnosed as having diabetes. In all other patients, a diagnosis will be established according to the criteria of the American Diabetes Association
  • Sarcopenia (non-severe): individuals with low muscle mass and either low muscle strength or low physical performance will be diagnosed with sarcopenia, according to the criteria of the European Working Group on Sarcopenia in Older People (EWGSOP)
  • Healthy volunteers: no diabetes, no sarcopenia and none of the exclusion criteria

Exclusion Criteria (overall population):

  • acute diseases,
  • chronic obstructive pulmonary disease (COPD)
  • conditions associated with sarcopenia/altered body composition (e.g. disability, altered endocrine function, chronic diseases, nutritional deficiencies, cancer),
  • obesity (body mass index ≥30 kg/m2)
  • moderate-severe hepatic disease,
  • chronic kidney disease (estimated glomerular filtration rate \<30 ml/min per 1.73m2),
  • metal prostheses,
  • recent or ongoing infection,
  • inability or unwillingness to provide informed consent

Exclusion Criteria (diabetic population):

  • type 1 diabetes,
  • hemoglobin A1c >8.5% (69 mmol/mol),
  • basal-bolus insulin therapy,
  • insulin pump therapy,
  • proliferative diabetic retinopathy,
  • diabetic foot.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
76 participants (actual)
Patient registry
No

Groups and cohorts

  • HE

    Healthy elderlies

  • DM

    Elderlies with type 2 diabetes

  • SA

    Elderlies with sarcopenia

  • DS

    Elderlies with both type 2 diabetes and sarcopenia

06

What researchers measure

Primary outcomes

  1. Inflammatory markers (TNF-α, interleukin-1, interleukin-2, interleukin-6, RANKL, Myostatin and GDF11)

    The primary objective of the study is to detect differences in inflammatory markers in the four groups

    Time frame: 2 years

07

Study locations

2 sites
  • Catholic University of Sacred Heart
    Rome, 00168, Italy
  • Ospedale San Giovanni Calibita - Fatebenefratelli Isola Tiberina
    Rome, 00186, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02426073
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators
University of Rome Tor Vergata, Fondazione Roma
Responsible party
Giaccari Andrea (MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Apr 24, 2015
Start date
Jan 2017
Primary completion
Feb 2022
Completion
Feb 2022
Last update
Apr 19, 2023
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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