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

Obesity Clinical Trial

— OB-KID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06338631
• Other study ID #: 43C301
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Istituto Auxologico Italiano
• Contact: Alberto Battezzati, Prof
• Phone: +390261911
• Email: a.battezzati[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Obesity

Intervention

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

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glomerular filtration rate	Change in glomerular filtration after dietary intervention of 12 months	At baseline and after 12 months of dietary intervention programme
Primary	Microalbuminuria	Change in microalbuminuria after dietary intervention of 12 months	At baseline and after 12 months of dietary intervention programme
Primary	Glycemia	Change in glycemia after dietary intervention of 12 months	At baseline and after 12 months of dietary intervention programme
Primary	Body mass index	Change in body mass index after dietary intervention of 12 months	At baseline and after 12 months of dietary intervention programme