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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06338631
Acronym
OB-KID
Enrollment
1000
Registered
2024-03-29
Start date
2023-08-01
Completion date
2025-12-31
Last updated
2025-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Metabolic phenotype, Renal function

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.

Interventions

OTHERDiet

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

Sponsors

Istituto Auxologico Italiano
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Glomerular filtration rateAt baseline and after 12 months of dietary intervention programmeChange in glomerular filtration after dietary intervention of 12 months
MicroalbuminuriaAt baseline and after 12 months of dietary intervention programmeChange in microalbuminuria after dietary intervention of 12 months
GlycemiaAt baseline and after 12 months of dietary intervention programmeChange in glycemia after dietary intervention of 12 months
Body mass indexAt baseline and after 12 months of dietary intervention programmeChange in body mass index after dietary intervention of 12 months

Countries

Italy

Contacts

Primary ContactAlberto Battezzati, Prof
a.battezzati@auxologico.it+390261911
Backup ContactLuca Grappiolo
luca.grappiolo@auxologico.it+390261911

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026