跳至主要内容
临床试验/NCT07830030
NCT07830030进行中(未招募)不适用

Effects of Metabolic Status on the Risk, at 5 Years, of Cardiovascular Events, Chronic Kidney Disease in Two Caribbean and Polynesian Populations With Morbid Obesity. Contribution of the "OBECAM" Cohort, for the Study of Obesity

Clinique1 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2025年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
480
试验地点
1
主要终点
Incidence or progression of CKD

研究概览

简要总结

Morbid obesity is defined by a body mass index (BMI) ≥ 40 kg/m2 or > 35 if there is at least one comorbidity (hypertension, diabetes, hypercholesterolemia, joint pain, obstructive sleep apnea syndrome, etc.) Morbid obesity significantly increases the prevalence of comorbidities, such as cardiovascular and metabolic diseases, chronic kidney disease (CKD), cancers, etc. .

The main objective is to assess, at 5 years, the incidence (or progression) of CKD, depending on the presence or absence of Metabolic Syndrome ( a combination of several cardiovascular risk factors), in 2 overseas populations (Caribbean and Polynesian) with morbid obesity.

We also aim to estimate at 5 years the incidence of complications other than CKD: metabolic diseases (diabetes, dyslipidemia), cardiovascular diseases (coronary artery disease, stroke) and death in the cohort and to evaluate the association between gene variants linked to central adiposity and/or CKD and the occurrence of events.

The risk factors to study are

- Metabolic syndrome (MetS) and its components

MetS define by presence of at least 3 of the following criteria:

  • Waist circumference ≥ 102 cm in men and ≥ 88 cm in women

  • Systolic blood pressure ≥ 130 and/or diastolic ≥ 85 mmHg

  • HDL-cholesterol < 1.04 mmol/L (40 mg/dL) in men, < 1.29 mmol/L (50 mg/dL) in women

  • Triglyceridemia ≥ 1.69 mmol/L (150 mg/L)

  • Fasting blood glucose ≥ 5.6 mmol/L (100 mg/dL)

  • Environmental and behavioral factors The design of the study

  • A Descriptive and comparative cross-sectional study, to i) describe the natural history of the disease, ii) estimate the prevalence of factors of interest, iii) make comparisons between groups, according to different parameters (including ethnicity).

  • A Longitudinal study with evaluation of the incidence of complications and deaths in the cohort.

The global Number of patients to include is : 480: (and 240 in Guadeloupe and 240 in French Polynesia)

The Inclusion criteria are: Individuals with a BMI ≥ 40 kg/m2 or > 35 if there is at least one comorbidity. Aged 18 to 76 years. Of both sexes. Having given their written consent.

Without a history of bariatric surgery or having benefited from this intervention for more than 5 years

The statistical analysis method includes:

  • A descriptive analysis for all parameters of interest, for all groups: Incidence of cardiovascular, metabolic and CKD complications Incidence of deaths

  • Comparisons between groups

  • Logistic regressions for

  • Measuring the association between MetS and complications

  • Measuring the association between gene variants,MetS, CKD and other complications.

  • COX proportional hazards models to specify the risk of occurrence of CKD and other complications and the risk of mortality, taking into account in particular MetS, the duration of follow-up

A better understanding of some clinical, metabolic and genetic aspects of morbid obesity and/or its complications is expected as well as benefits in terms of disease management.

Start of inclusions: March 3, 2025 End date of monitoring: December 31, 2030

详细描述

I. SCIENTIFIC RATIONALE AND GENERAL DESCRIPTION OF THE RESEARCH

  1. Introduction The population of the Guadeloupe department consists of a majority (80%) of individuals of African descent. Overall, the prevalence of obesity is 23% (31% among women and 12% among men). French Polynesia is reported to have one of the highest obesity rates in the world, at approximately 50% (https://la1ere.francetvinfo.fr/polynesie/tahiti/polynesie-francaise/taux-d-obesite-la-polynesie-francaise-possede-l-un-des-taux-les-plus-eleves-au-monde-1469895.html.) This research project on morbid obesity will be conducted in the Guadeloupe department and the territory of French Polynesia. It aims to study the effect of metabolic status on the incidence of cardiovascular events, chronic kidney disease, and death among individuals with morbid obesity. This study will be carried out as a 5-year longitudinal follow-up.

Some obese individuals may not exhibit metabolic disorders and can be classified as having "metabolically healthy obesity"(Stefan N, 2008; Wildman RP, 2008).

Other obese individuals present with metabolic syndrome (MetS). This syndrome encompasses a wide range of cardiometabolic risk factors-typically including central obesity, insulin resistance, hypertension, and dyslipidemia-that significantly increase the risk of developing numerous chronic conditions (such as cardiovascular disease [CVD], diabetes, chronic kidney disease [CKD], and cancer) (Li C, 2024 ; O'Neill S, 2015).

Morbid obesity results from a variety of influences, combining environmental, behavioral, hormonal, genetic, and medical factors. Individuals with morbid obesity face an increased risk of cardiovascular and renal complications.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient enrollment will be conducted consecutively. Individuals with a BMI ≥ 40 kg/m² or > 35 kg/m² with at least one comorbidity (hypertension, diabetes, hypercholesterolemia, joint pain, obstructive sleep apnea syndrome, etc.)
  • With no history of bariatric surgery, or having undergone such a procedure more than 5 years ago
  • Aged 18 years or older
  • Informed of the study objectives and constraints and having provided written consent; residents of Guadeloupe or French Polynesia

排除标准

  • Refusal to participate Individuals with acute renal failure; those undergoing dialysis Those who have undergone bariatric surgery within the last 5 years Pregnant women, women in labor, and breastfeeding mothers Persons deprived of liberty by a judicial or administrative decision; persons subject to psychiatric care Minors Adults subject to legal protection measures or unable to provide consent

研究组 & 干预措施

Five-year follow-up of participants with morbid obesity to identify the onset of CKD.

The cohorte includes participants with morbid obesity in French Polynesia and in Guadeloupe

Morbidly obese Guadeloupean and Polynesian cohort

Follow up of morbidly obese individuals. Clinical and biological examinations. Diagnosis of genetic

The cohorte includes Guadeloupean and Polynesian individuals

The "OBECAM" cohort for the study of Obesity and Comorbidities in French overseas regions includes C

This "OBECAM cohort" will make possible to study the natural history of this disease and to determine in particular the incidence of complications depending on the existence or not of certain parameters of interest, including metabolic syndrome

结局指标

主要结局

Incidence or progression of CKD

时间窗: After 5 years

CKD incidence, in individuals who did not have CKD at cohort entry (T0), is defined as the presence of 1+ or greater proteinuria on routine urinalysis (dipstick) and/or an estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73 m². CKD progression, in individuals who had CKD at T0, is defined as a decrease in eGFR of at least 30% compared to baseline (T0).

次要结局

未报告次要终点

研究者

发起方
Clinique
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验