Early Detection of Renal Abnormalities in Metabolically Healthy and Unhealthy Weight Excess" (OB-KID)
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.
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Luca Grappiolo
- Phone Number: 2894 +390261911
- Email: luca.grappiolo@auxologico.it
Study Contact Backup
- Name: Alberto Battezzati, Prof
- Phone Number: +390261911
- Email: a.battezzati@auxologico.it
Study Locations
-
-
-
Milano, Italy, 20100
- Recruiting
- Istituto Auxologico Italiano, Città Studi ICANS
-
Contact:
- Alberto Battezzati, Prof
- Phone Number: +390261911
- Email: a.battezzati@auxologico.it
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Naples, 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
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Contact:
- Bruna Guida, Prof.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adults with weight excess
|
Pesonalized diet plan, devoloped according to Guidelines for dietary treatment of obesity, to be followed for a duration of 12 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glomerular filtration rate
Time Frame: At baseline and after 12 months of dietary intervention programme
|
Change in glomerular filtration after dietary intervention of 12 months
|
At baseline and after 12 months of dietary intervention programme
|
|
Microalbuminuria
Time Frame: At baseline and after 12 months of dietary intervention programme
|
Change in microalbuminuria after dietary intervention of 12 months
|
At baseline and after 12 months of dietary intervention programme
|
|
Glycemia
Time Frame: At baseline and after 12 months of dietary intervention programme
|
Change in glycemia after dietary intervention of 12 months
|
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
|
Change in body mass index after dietary intervention of 12 months
|
At baseline and after 12 months of dietary intervention programme
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 43C301
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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