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NCT06338631Recruiting

Early Detection of Renal Abnormalities in Metabolically Healthy and Unhealthy Weight Excess"

Source: ClinicalTrials.gov · Last updated 3 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Overweight and obesity are increasingly prevalent worldwide. Weight excess increases the risk of in developing the metabolic syndrome, which is composed by a set of cardiometabolic risk factors such as abdominal adiposity, dyslipidemia, high blood pressure and elevated fasting glucose levels. Obesity and the metabolic syndrome are known to be risk factors for the development of chronic kidney disease. It is not clear however, whether they can be considered independent risk factors for impaired renal function and renal damage. Whereas obesity may represent an independent risk factor for renal damage, it is not clear yet if the contemporaneous presence of obesity and metabolic alterations is associated with an additional increase in the risk. It may be important to understand the relationship between obesity, metabolic syndrome and renal health, as treatment strategies may be different for the two metabolic phenotypes of obesity, i.e., metabolically healthy obese (MHO) and metabolically unhealthy obese (MUO) patients. The primary objective of this multicentre observational prospective study is to assess the relationship between metabolic phenotype and reduced renal function (glomerular filtration rate \<90 ml/min/1.73m2 or microalbuminuria 30-300 mg/24h) in a population of 1000 patients with overweight or obesity. The secondary aim is to study the association between diet quality, consumption of ultra-processed foods and indicators of reduced renal function and renal damage.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1000 (estimated)
First submitted
24 Mar 2024
Start date
1 Aug 2023
Primary completion date
31 Dec 2025
Lead sponsor
Istituto Auxologico Italiano
Diseases
Obesity
NCT number
NCT06338631

What you commit to

  • Study type: Observational
  • Planned participants: 1000
  • From 1 Aug 2023 to the primary completion date, 31 Dec 2025
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Pharmacologcal treatment with RAAS-inhibitors, sartans, thiazide diuretics, loop diuretics

Other illness

  • Diabetes mellitus
  • Renal disease
  • Systemic autoimmune diseases with possible renal involvement
  • Heart failure
  • Urinary tract infection

Other

  • Pregnancy or breastfeeding
  • Agonistic physical activity

Who the study is looking for

  • Age between 18 and 60 years
  • BMI at least 25 kg/m2

Age in the registry: 18 years to 60 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Istituto Auxologico Italiano, Città Studi ICANS
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Programma Infradipartimentale di Dietoterapia nel Trapianto e nell' Insufficienza Renale Cronica, DAI di Medicina Interna ad Indirizzo Specialistico, del Policlinico Federico II di Napoli
Coordinator of this site? Confirm its status
NaplesItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.