Detecting kidney issues in people with obesity and metabolic health variations
Early Detection of Renal Abnormalities in Metabolically Healthy and Unhealthy Weight Excess"
This study is trying to see if being obese and having metabolic issues affect kidney health in adults aged 18 to 60, while also testing how diet changes might help.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 2 sites (Milan and 1 other locations) |
| Trial ID | NCT06338631 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between obesity, metabolic syndrome, and renal health. It focuses on understanding whether obesity and metabolic alterations independently increase the risk of renal damage. Participants aged 18 to 60 with a BMI of at least 25 kg/m2 will be observed, with a particular emphasis on differentiating between metabolically healthy obese individuals and those with metabolic complications. The study will involve dietary interventions to assess their impact on renal function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with a BMI of 25 kg/m2 or higher.
Not a fit: Patients with diabetes, renal disease, or systemic autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to tailored treatment strategies for obesity-related renal health issues.
How similar studies have performed: While the relationship between obesity and renal health has been studied, this specific approach focusing on metabolic phenotypes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 60 years * BMI at least 25 kg/m2 Exclusion Criteria: * Pregnancy or breastfeeding * Diabetes mellitus * Renal disease * Systemic autoimmune diseases with possible renal involvement * Agonistic physical activity * Heart failure * Pharmacologcal treatment with RAAS-inhibitors, sartans, thiazide diuretics, loop diuretics * Urinary tract infection
Where this trial is running
Milan and 1 other locations
- Istituto Auxologico Italiano, Città Studi ICANS — Milan, Italy (Recruiting)
- Programma Infradipartimentale di Dietoterapia nel Trapianto e nell' Insufficienza Renale Cronica, DAI di Medicina Interna ad Indirizzo Specialistico, del Policlinico Federico II di Napoli — Naples, Italy (Recruiting)
Study contacts
- Study coordinator: Alberto Battezzati, Prof
- Email: a.battezzati@auxologico.it
- Phone: +390261911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.