The Impact of Misclassification of Obesity by Body Mass Index on Mortality in Patients With Chronic Kidney Disease

Obesity Clinical Trial

Official title:

The Impact of Misclassification of Obesity by Body Mass Index on Mortality in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03285074
• Other study ID #: 99-IRB-016-XD
• Status: Completed
• Phase: N/A
• First received: September 14, 2017
• Last updated: September 14, 2017
• Start date: November 1, 2011
• Est. completion date: March 31, 2017

Study information

• Verified date: September 2017
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: March 31, 2017
• Est. primary completion date: December 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Obesity
• Renal Insufficiency, Chronic

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

References & Publications (3)

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. — View Citation

Gracia-Iguacel C, Qureshi AR, Avesani CM, Heimbürger O, Huang X, Lindholm B, Bárány 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause mortality	all-cause mortality	medium follow up 4.9 years