Clinical trial NCT06338631: Early Detection of Renal Abnormalities in Metabolically Healthy and Unhealthy Weight Excess"
Official title: Early Detection of Renal Abnormalities in Metabolically Healthy and Unhealthy Weight Excess"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Keywords: Metabolic phenotype
Renal function
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1000 patients with weight excess or overweight (BMI \> 25 kg/m2)

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.


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

Primary outcomes:
measure: Glomerular filtration rate
timeFrame: At baseline and after 12 months of dietary intervention programme
measure: Microalbuminuria
timeFrame: At baseline and after 12 months of dietary intervention programme
measure: Glycemia
timeFrame: At baseline and after 12 months of dietary intervention programme
measure: Body mass index
timeFrame: At baseline and after 12 months of dietary intervention programme
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Auxologico Italiano, Città Studi ICANS
city: Naples
country: Italy
facility: Programma Infradipartimentale di Dietoterapia nel Trapianto e nell' Insufficienza Renale Cronica, DAI di Medicina Interna ad Indirizzo Specialistico, del Policlinico Federico II di Napoli
Study officials:
References: