CClinicalTrials.gg
RecruitingNCT06338631OB-KIDUpdated Aug 3, 2025

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

An observational study in Obesity, sponsored by Istituto Auxologico Italiano. Recruiting at 2 sites in Italy. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-08-03.

Sponsored by Istituto Auxologico Italiano · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Obesity

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Keywords

  • Metabolic phenotype
  • Renal function
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Istituto Auxologico Italiano is the lead sponsor of 196 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

1000 patients with weight excess or overweight (BMI > 25 kg/m2)

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Adults with weight excess

    Other: Diet

Interventions

  • OtherDiet

    Pesonalized diet plan, devoloped according to Guidelines for dietary treatment of obesity, to be followed for a duration of 12 months

06

What researchers measure

Primary outcomes

  1. Glomerular filtration rate

    Change in glomerular filtration after dietary intervention of 12 months

    Time frame: At baseline and after 12 months of dietary intervention programme

  2. Microalbuminuria

    Change in microalbuminuria after dietary intervention of 12 months

    Time frame: At baseline and after 12 months of dietary intervention programme

  3. Glycemia

    Change in glycemia after dietary intervention of 12 months

    Time frame: At baseline and after 12 months of dietary intervention programme

  4. Body mass index

    Change in body mass index after dietary intervention of 12 months

    Time frame: At baseline and after 12 months of dietary intervention programme

07

Study locations

2 of 2 sites recruiting
  • Istituto Auxologico Italiano, Città Studi ICANS
    Milan, 20100, 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
    • Bruna Guida, Prof. · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06338631
Lead sponsor
Istituto Auxologico Italiano
Responsible party
Sponsor
First posted
Mar 29, 2024
Start date
Aug 1, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Aug 3, 2025

Study contacts

Alberto Battezzati, Prof
Contact
a.battezzati@auxologico.it
+390261911
Luca Grappiolo
Contact
luca.grappiolo@auxologico.it
+390261911 ext. 2894

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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