NCT03285074

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

1.1 years

First QC Date

September 14, 2017

Last Update Submit

September 14, 2017

Conditions

Chronic Kidney DiseasesObesity

Keywords

Diagnostic discordance of obesityall-cause mortality

Outcome Measures

Primary Outcomes (1)

  • all-cause mortality

    all-cause mortality

    medium follow up 4.9 years

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with nondialysis CKD with eGFR \< 60ml/min/1.73m2

You may qualify if:

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

You may not qualify if:

  • subjects with liver cirrhosis
  • subjects with malignancy
  • amputee
  • pregnancy
  • subjects with pacemaker
  • subjects with metallic implant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 25392147RESULT

  • 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.

    PMID: 20876448RESULT

  • 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.

    PMID: 24179011RESULT

  • 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.

    PMID: 30321257DERIVED

  • 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.

    PMID: 29635500DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicObesity

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and Symptoms

Study Officials

  • Szu-Chun Hung, MD

    Division of nephrology, Taipei Tzu Chi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 15, 2017

Study Start

November 1, 2011

Primary Completion

December 1, 2012

Study Completion

March 31, 2017

Last Updated

September 15, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share