Recruiting

Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity

I'm interested View official listing

ClinicalTrials.gov IDNCT06438900

PhaseNot Applicable

Enrollment195

SponsorAzienda Ospedaliero Universitaria Maggiore della Carita

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

Sarcopenia, Obesity

About this study

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.

Primary outcomes

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)

Eligibility information

Inclusion Criteria: * Patients of both sexes. * Adults. * BMI compatible with obesity and a diagnosis of type 2 diabetes under good metabolic control (HbA1c \< 7.5%) within 15 years of entry into the study or diagnosis of lipodystrophy (included in the European Consortium of Lipodystrophies (ECLip) Registry (eclip-web.org)) Exclusion Criteria: * Age under 18 years. * Secondary obesity or genetic diseases (Prader-Willi Syndrome, Down Syndrome); metabolic and endocrine disorders (Cushing's syndrome, hypothyroidism). * Subjects with: Inflammatory Bowel Disease (IBD), cancer. * Confirmed or planned pregnancy during the study participation months.

Study locations

SCDU Endocrinology, AOU Ospedale Maggiore della Carità, Novara, 28100 Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-04.