Chronic Kidney DiseasesNCT03285074
The Impact of Misclassification of Obesity by Body Mass Index on Mortality in Patients With Chronic Kidney Disease
An observational study of Chronic Kidney Diseases and Obesity, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Kidney Diseases, Obesity
- How many people
- 326 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2011to 31 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with nondialysis CKD with eGFR < 60ml/min/1.73m2
Who may be able to join
- Subjects with non-dialysis CKD defined as estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2
Who cannot join
- 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
About this study
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.
- Conditions
- Chronic Kidney Diseases, Obesity
- Being tested
- No intervention
- Keywords
- Diagnostic discordance of obesity, all-cause mortality
- Medical subject headings
- Renal Insufficiency, Chronic, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
all-cause mortality
Measured: medium follow up 4.9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start1 Nov 2011
- Primary completion1 Dec 2012
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Szu-Chun Hung, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Investigators
- Szu-Chun Hung, MD, Principal investigator, Division of nephrology, Taipei Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285074
- Sponsor's protocol ID
- 99-IRB-016-XD
- Status last verified
- Sep 2017
- First submitted
- 14 Sep 2017
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25392147Agarwal 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.
PubMed 20876448Gracia-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.
PubMed 24179011Lin 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.
PubMed 30321257Lin 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.
PubMed 29635500
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Misclassification of Obesity by Body Mass Index on Mortality in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03285074
- Acronym / sponsor ID
- 99-IRB-016-XD
- Conditions
- Chronic Kidney Diseases, Obesity
- Keywords
- Diagnostic discordance of obesity, all-cause mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 1 Dec 2012 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 15 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with nondialysis CKD with eGFR < 60ml/min/1.73m2
Key inclusion criteria (1 listed)
- Subjects with non-dialysis CKD defined as estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2
Key exclusion criteria (7 listed)
- subjects with liver cirrhosis
- subjects with malignancy
- subjects with an acute cardiovascular event within the 3 months before screening for inclusion
- amputee
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
all-cause mortality
Time frame: medium follow up 4.9 years
all-cause mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Results publication: PubMed 25392147Sharma 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.
- Results publication: PubMed 20876448Agarwal 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.
- Results publication: PubMed 24179011Gracia-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.
- Derived from this study: PubMed 30321257Lin 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.
- Derived from this study: PubMed 29635500Lin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Szu-Chun Hung, MD principal investigator
Division of nephrology, Taipei Tzu Chi Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Obesity, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: medium follow up 4.9 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03285074, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.