Body Fat Mass Association With Clinical Metabolic Profiles, Markers of Inflammation and Adipocytokines
Body Fat Mass as Predictors of Survival in Hemodialysis Patients and Its Association With Clinical Metabolic Profiles, Markers of Inflammation and Adipocytokines in Chronic Hemodialysis Patients: a Prospective Study.
1 other identifier
observational
65
0 countries
N/A
Brief Summary
Overweight and obesity have become an increasing problem in patients on hemodialysis. However, in virtually all observational studies in chronic kidney disease(CKD) and dialysis patients , using body mass index(BMI) as metric fat mass is associated inversely with death rate. Nevertheless, it is questionable that obesity can be considered an unequivocal protective factor in chronic diseases as increase body fat mass appears to be a potential cause of the chronic inflammation frequently present in these patients. The consequences of this inflammation are impaired nutritional status, accelerated atherosclerosis, and increased mortality. In the present study, by using dual-energy X-ray absorptiometry (DEXA) and bioimpedance spectroscopy (BIS) to evaluated the contributions of fat mass to outcomes in an observational cohort of hemodialysis patients. Besides, we aim to assess the relationship between body fat composition, clinical metabolic risk profiles, measures of adiposity, such as waist circumference (WC), visceral adiposity index, waist-to-hip ratio (WHR), and waist-to-height ratio (WHtR), markers of inflammation and adipocytokines in these maintenance hemodialysis patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2014
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 26, 2016
CompletedFirst Posted
Study publicly available on registry
June 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 20, 2017
February 1, 2017
2.8 years
May 26, 2016
February 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurence of CVD events
A DEXA scan is used to measure total and segmental lean(kg), total body fat mass(kg), and bone mineral content(kg). A BIS is used to measurefree fat mass(Kg), lean body mass(Kg),ICW(L) and ECW(L).
3 years
Secondary Outcomes (2)
Correlates of metabolic syndrome
3 years
Presence of inflammation
3 years
Eligibility Criteria
hemodialysis (HD) patients
You may qualify if:
- Both sexes aged \> 20 years-old. Received stable hemodialysis at least 3 months. Written informed consent.
You may not qualify if:
- Patients with malignant disease, acute infectious disease, acute inflammatory disease (such as collagen disease), and advanced liver disease are excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2016
First Posted
June 15, 2016
Study Start
March 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
February 20, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will share