Metabolic Status and Risk of Chronic Kidney Disease in French Overseas Populations With Morbid Obesity (OBECAMcohort).

Brief summary (registry, in English)

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

What you commit to

• Study type: Observational
• Planned participants: 480
• From 3 Mar 2025 to the primary completion date, Dec 2030
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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