Early Detection of Renal Abnormalities in Metabolically Healthy and Unhealthy Weight Excess" (OB-KID)

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Other: Diet

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Luca Grappiolo; Phone Number: 2894 +390261911; Email: luca.grappiolo@auxologico.it
• Study Contact Backup: Name: Alberto Battezzati, Prof; Phone Number: +390261911; Email: a.battezzati@auxologico.it

Study Locations

• Italy
  • Milano, Italy, 20100
    • Recruiting
    • Istituto Auxologico Italiano, Città Studi ICANS
    • Contact: Alberto Battezzati, Prof; Phone Number: +390261911; Email: a.battezzati@auxologico.it
  • Naples, 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
    • Contact: Bruna Guida, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults with weight excess	Other: Diet; Pesonalized diet plan, devoloped according to Guidelines for dietary treatment of obesity, to be followed for a duration of 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glomerular filtration rate	Change in glomerular filtration after dietary intervention of 12 months	At baseline and after 12 months of dietary intervention programme
Microalbuminuria	Change in microalbuminuria after dietary intervention of 12 months	At baseline and after 12 months of dietary intervention programme
Glycemia	Change in glycemia after dietary intervention of 12 months	At baseline and after 12 months of dietary intervention programme
Body mass index	Change in body mass index after dietary intervention of 12 months	At baseline and after 12 months of dietary intervention programme

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 24, 2024
• First Submitted That Met QC Criteria: March 24, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Renal function; Metabolic phenotype
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 43C301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No