Clinical trial NCT02426073: Glucose Metabolism, Muscle Mass/Function and Inflammation in the Elderly
Official title: Pilot Observational Study to Characterize Glucose Metabolism, Muscle Mass/Function and Inflammatory Profile in Elderly Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Diabetes Mellitus
Keywords: Inflammaging
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: University of Rome Tor Vergata
name: Fondazione Roma
First posted: 2015-04-24
Enrollment: 76
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly (≥ 70 years) subjects

Brief 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.


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.

Primary outcomes:
measure: Inflammatory markers (TNF-α, interleukin-1, interleukin-2, interleukin-6, RANKL, Myostatin and GDF11)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of Sacred Heart
city: Rome
country: Italy
facility: Ospedale San Giovanni Calibita - Fatebenefratelli Isola Tiberina
Study officials:
References: