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NCT Number: NCT06338631

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Auxologico Italiano, Città Studi ICANS, Milan, Italy

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Other

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

Primary outcomes

  1. 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

  2. Microalbuminuria

    Time frame: At baseline and after 12 months of dietary intervention programme

    Change in microalbuminuria after dietary intervention of 12 months

  3. Glycemia

    Time frame: At baseline and after 12 months of dietary intervention programme

    Change in glycemia after dietary intervention of 12 months

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alberto Battezzati, Prof

CONTACT

[email protected]

+390261911

Luca Grappiolo

CONTACT

[email protected]

+390261911 ext. 2894

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Acronym: OB-KID

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 29, 2024
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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