Early Detection of Renal Abnormalities in Metabolically Healthy and Unhealthy Weight Excess"
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diet.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Diet
Pesonalized diet plan, devoloped according to Guidelines for dietary treatment of obesity, to be followed for a duration of 12 months
Primary outcome measures
- Glomerular filtration rate [Time frame: At baseline and after 12 months of dietary intervention programme]
- Microalbuminuria [Time frame: At baseline and after 12 months of dietary intervention programme]
- Glycemia [Time frame: At baseline and after 12 months of dietary intervention programme]
- Body mass index [Time frame: At baseline and after 12 months of dietary intervention programme]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Italy · 2 centers
- Istituto Auxologico Italiano, Città Studi ICANS — Milan
- Programma Infradipartimentale di Dietoterapia nel Trapianto e nell' Insufficienza Renale C — Naples
Identifiers
NCT: NCT06338631 · 43C301