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

NCT06338631 | Recruiting

• 1 other identifier: 43C301
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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

Keywords

Metabolic phenotype; Renal function

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Adults with weight excess

Other: Diet

Interventions

Diet OTHER

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

Adults with weight excess

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (2)

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

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Alberto Battezzati, Prof

CONTACT

+390261911; a.battezzati@auxologico.it

Luca Grappiolo

CONTACT

+390261911; luca.grappiolo@auxologico.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: March 29, 2024
• Study Start: August 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

IT (2)