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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sarcopenia, Diabetes Mellitus

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HE<br>Healthy elderlies | |
| DM<br>Elderlies with type 2 diabetes | |
| SA<br>Elderlies with sarcopenia | |
| DS<br>Elderlies with both type 2 diabetes and sarcopenia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammaging