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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02426073

Enrollment

Registered

2015-04-24

Start date

2017-01-31

Completion date

2022-02-28

Last updated

2023-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Sarcopenia

Keywords

Inflammaging

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Inflammatory markers (TNF-α, interleukin-1, interleukin-2, interleukin-6, RANKL, Myostatin and GDF11)	2 years	The primary objective of the study is to detect differences in inflammatory markers in the four groups

Countries

Italy

Outcome results