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

NCT ID: NCT06338631

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adults with weight excess

Diet

Intervention Type: OTHER

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

Interventions

Diet

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Auxologico Italiano, Città Studi ICANS

Milan, , Italy

Site Status: 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

Site Status: RECRUITING

Countries

Italy

Central Contacts

Alberto Battezzati, Prof

Role: CONTACT

a.battezzati@auxologico.it

+390261911

Luca Grappiolo

Role: CONTACT

luca.grappiolo@auxologico.it

+390261911 ext. 2894

Facility Contacts

Alberto Battezzati, Prof

Role: primary

a.battezzati@auxologico.it

+390261911

Bruna Guida, Prof.

Role: primary

Other Identifiers

43C301

Identifier Type: -

Identifier Source: org_study_id