Exploring the connection between diet-related muscle loss and obesity in patients with type 2 diabetes
Official title: Fighting Western-diet Derived AGEs to Mitigate Muscle Wasting in Sarcobesity:Observational Study on the Relationship Between AGE Levels and Sarcobesity in an Adult Population Affected by Obesity and Type 2 Diabetes Mellitus
Run by Azienda Ospedaliero Universitaria Maggiore della Carita · NCT06438900 · Data updated 2026-11-12
This study looks at how certain harmful substances in food might cause muscle loss in people with obesity and type 2 diabetes to see if it affects their overall health.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 195 (estimated) |
| Sponsor | Azienda Ospedaliero Universitaria Maggiore della Carita Academic / other |
| Locations | 1 site (Novara) |
| Status | Recruiting |
| Started | June 15, 2024 |
| Main results expected | May 15, 2026 |
| Study ends | May 15, 2027 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT06438900 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults with obesity and a diagnosis of type 2 diabetes or lipodystrophy within 15 years of study entry.
✕Probably not a fit
Patients under 18 years, those with secondary obesity, genetic disorders, or certain inflammatory and cancer conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the relationship between advanced glycation end products (AGEs) and muscle wasting in adults with obesity and type 2 diabetes or lipodystrophy. It aims to determine how dietary AGEs contribute to muscle loss and the progression of sarcopenia, which may lead to severe metabolic issues. The study will evaluate circulating AGE levels in the skin and correlate these with the stage of sarcopenia in participants. Additionally, it will analyze clinical data to identify relevant metabolites and metabolic pathways involved in this process.
Why it matters
Potential benefit: If successful, this study could lead to targeted interventions that mitigate muscle loss and improve metabolic health in patients with obesity and type 2 diabetes.
How similar studies have gone: While the specific approach of linking AGEs to muscle wasting in this context is novel, related studies have explored the impact of diet on metabolic health and muscle loss.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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SCDU Endocrinology, AOU Ospedale Maggiore della Carità
Novara, Italy Recruiting
Study contacts
- Principal investigator: Flavia Prodam, MD PhD — AOU Maggiore della Carità di Novara
- Study coordinator: Flavia Prodam, MD PhD
- Email: flavia.prodam@med.uniupo.it
- Phone: +39-0321-660693
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.