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

Recruiting

• Conditions: Obesity
• Interventions: Other: Diet

• Registration Number: NCT06338631
• Lead Sponsor: Istituto Auxologico Italiano

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-24
• Study First Submitted QC: 2024-03-24
• Last Update Submitted: 2024-03-24
• Study First Posted: 2024-03-29
• Last Update Posted: 2024-03-29
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults with weight excess	Diet	-

Primary Outcome Measures

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

Trial Locations

Locations (2)

Istituto Auxologico Italiano, Città Studi ICANS; 🇮🇹 Milano, Italy

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