Actively Recruiting

Age: 18Years - 60Years
All Genders
NCT06338631

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

Led by Istituto Auxologico Italiano · Updated on 2025-08-03

1000

Participants Needed

2

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 60 years
  • Body mass index (BMI) of at least 25 kg/m2
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Diabetes mellitus
  • Kidney disease
  • Systemic autoimmune diseases with possible kidney involvement
  • Agonistic physical activity
  • Heart failure
  • Treatment with RAAS-inhibitors, sartans, thiazide diuretics, or loop diuretics
  • Urinary tract infection

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Istituto Auxologico Italiano, Città Studi ICANS

Milan, Italy, 20100

Actively Recruiting

2

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

Actively Recruiting

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Research Team

A

Alberto Battezzati, Prof

CONTACT

L

Luca Grappiolo

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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