NCT06438900 Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
| NCT ID | NCT06438900 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliero Universitaria Maggiore della Carita |
| Condition | Sarcopenia |
| Study Type | OBSERVATIONAL |
| Enrollment | 195 participants |
| Start Date | 2024-06-15 |
| Primary Completion | 2026-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 195 participants in total. It began in 2024-06-15 with a primary completion date of 2026-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Flavia Prodam, MD PhD
PRINCIPAL INVESTIGATOR
AOU Maggiore della Carità di Novara
Frequently Asked Questions
Who can join the NCT06438900 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sarcopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06438900 currently recruiting?
Yes, NCT06438900 is actively recruiting participants. Contact the research team at flavia.prodam@med.uniupo.it for enrollment information.
Where is the NCT06438900 trial being conducted?
This trial is being conducted at Novara, Italy.
Who is sponsoring the NCT06438900 clinical trial?
NCT06438900 is sponsored by Azienda Ospedaliero Universitaria Maggiore della Carita. The principal investigator is Flavia Prodam, MD PhD at AOU Maggiore della Carità di Novara. The trial plans to enroll 195 participants.