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OpenTrials
Completed

NCT Number: NCT02426073

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

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.

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Key information

Conditions

Sarcopenia Atrophy Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Catholic University of Sacred Heart, Rome, Italy

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Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Fondazione Roma
  • University of Rome Tor Vergata

Registry information

Official study title

Pilot Observational Study to Characterize Glucose Metabolism, Muscle Mass/Function and Inflammatory Profile in Elderly Individuals

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Apr 24, 2015
Registry last updated
Apr 19, 2023

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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