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临床试验/NCT06338631
NCT06338631招募中不适用

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

Istituto Auxologico Italiano2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
2
主要终点
Microalbuminuria

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 60 years
  • BMI at least 25 kg/m2

排除标准

  • 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

结局指标

主要结局

Microalbuminuria

时间窗: At baseline and after 12 months of dietary intervention programme

Change in microalbuminuria after dietary intervention of 12 months

Body mass index

时间窗: At baseline and after 12 months of dietary intervention programme

Change in body mass index after dietary intervention of 12 months

Glomerular filtration rate

时间窗: At baseline and after 12 months of dietary intervention programme

Change in glomerular filtration after dietary intervention of 12 months

Glycemia

时间窗: At baseline and after 12 months of dietary intervention programme

Change in glycemia after dietary intervention of 12 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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