Clinical trial NCT03285074: The Impact of Misclassification of Obesity by Body Mass Index on Mortality in Patients With Chronic Kidney Disease
Official title: The Impact of Misclassification of Obesity by Body Mass Index on Mortality in Patients With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Obesity
Keywords: Diagnostic discordance of obesity
all-cause mortality
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with nondialysis CKD with eGFR \< 60ml/min/1.73m2

Brief summary: Unlike the general population, a higher body mass index (BMI) is associated with greater survival among patients with chronic kidney disease (CKD). However, obesity is defined as excess body fat that associated with clearly elevated health risks according to the World Health Organization. In addition, muscle wasting is prevalent among CKD subjects. Thus, we hypothesized that different definition of obesity, based on BMI or body fat percentage, might have different impact on clinical outcomes among CKD population.


Eligibility criteria: Inclusion Criteria:

* Subjects with non-dialysis CKD defined as estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73 m2

Exclusion Criteria:

* subjects with liver cirrhosis
* subjects with malignancy
* subjects with an acute cardiovascular event within the 3 months before screening for inclusion
* amputee
* pregnancy
* subjects with pacemaker
* subjects with metallic implant

Primary outcomes:
measure: all-cause mortality
timeFrame: medium follow up 4.9 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Division of nephrology, Taipei Tzu Chi Hospital
name: Szu-Chun Hung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharma D, Hawkins M, Abramowitz MK. Association of sarcopenia with eGFR and misclassification of obesity in adults with CKD in the United States. Clin J Am Soc Nephrol. 2014 Dec 5;9(12):2079-88. doi: 10.2215/CJN.02140214. Epub 2014 Nov 12.
citation: Agarwal R, Bills JE, Light RP. Diagnosing obesity by body mass index in chronic kidney disease: an explanation for the "obesity paradox?". Hypertension. 2010 Nov;56(5):893-900. doi: 10.1161/HYPERTENSIONAHA.110.160747. Epub 2010 Sep 27.
citation: Gracia-Iguacel C, Qureshi AR, Avesani CM, Heimburger O, Huang X, Lindholm B, Barany P, Ortiz A, Stenvinkel P, Carrero JJ. Subclinical versus overt obesity in dialysis patients: more than meets the eye. Nephrol Dial Transplant. 2013 Nov;28 Suppl 4:iv175-81. doi: 10.1093/ndt/gft024.
citation: Lin TY, Liu JS, Hung SC. Obesity and risk of end-stage renal disease in patients with chronic kidney disease: a cohort study. Am J Clin Nutr. 2018 Nov 1;108(5):1145-1153. doi: 10.1093/ajcn/nqy200.
citation: Lin TY, Lim PS, Hung SC. Normal-weight obesity and clinical outcomes in nondiabetic chronic kidney disease patients: a cohort study. Am J Clin Nutr. 2018 Apr 1;107(4):664-672. doi: 10.1093/ajcn/nqy006.