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Life sciences · Observational Study
ClinicalTrials.gov · October 29, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT06438900). This is a study registration, not published results. Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 195 participants (ESTIMATED). Conditions: Sarcopenia, Obesity. Primary outcome measures: Skeletal mass functionality for sarcopenia definition , evaluation of sarcopenia state through study completion, an average of 1 year; Skeletall mass fuctionality for sarcopenia definition , evaluation of sarcopenia state through study completion, an average of 1 year; Skeletall mass calculation for sarcopenia definition , evaluation of sarcopenia state through study completion, an average of 1 year; Number of participants with sarcopenia , evaluation of sarcopenia state through study completion, an average of 1 year; Advanced glycation end products quantification , evaluation of AGEs through study completion, an average of 1 year; Endogenous and exogenous AGEs plasma quantification , evaluation of AGEs through study completion, an average of 1 year. Brief summary: The study aims to explore whether a high level of AGEs (Advanced Glycation end products) derived from the diet may mediate diet-related muscle loss in Western-type diet, influencing the onset and progression of sarcopenia, predisposing to earlier and more severe metabolic consequences, including type 2 diabetes (T2D). The primary objective of the study is to investigate how the accumulation of AGEs is correlated with muscle loss in adult patients with obesity and type 2 diabetes or lipodystrophy in order to identify possible targets to mitigate the metabolic alterations caused by the Western diet (WD). Specifically, circulating AGEs levels on the skin will be evaluated and correlated with the stage of sarcopenia in a group of patients with obesity and a T2D diagnosis. Furthermore, the relationship between disease duration and AGE levels will be assessed. A secondary objective will be to analyze the clinical data obtained to identify metabolites and metabolic pathways responsible for the phenotype induced by the WD. The ultimate aim of the study is therefore to verify whether high levels of AGEs are correlated with an early and/or more pronounced onset of sarcopenia, concurrently with an increase in inflammation and oxidative stress.