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

Completed

• Conditions: Diabetes Mellitus; Sarcopenia

• Registration Number: NCT02426073
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-21
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-24
• Study Start: 2017-01
• Primary Completion: 2022-02
• Study Completion: 2022-02
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Ospedale San Giovanni Calibita - Fatebenefratelli Isola Tiberina; 🇮🇹 Rome, Italy

Catholic University of Sacred Heart; 🇮🇹 Rome, Italy