NCT02718612

Brief Summary

Uraemic sarcopenia is complex, and progressive . As older persons are particularly susceptible to renal failure and this accelerates the physiological muscle wasting in this patient group. Hence sarcopenia is an important factor of functional impairment in elderly patients suffering from chronic kidney disease. On the other hand, overweight has become increasing common in dialysis patients, and is paradoxically reported to be associated with better survival. It remains unclear if adipose tissue in overweight in elderly dialysis patients is a source of proinflammatory mediators, which could contribute to protein-energy wasting (PEW), cardiovascular disease, and increased mortality. This study attempts to explore the prevalence of Sarcopenic Obesity (SO) in a cohort of hemodialysis patients with a more well defined criteria. In addition, this study aims to examine the association between sarcopenia and SO with metabolic and cardiovascular risk factors in these patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 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

March 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

March 4, 2016

Last Update Submit

February 15, 2017

Conditions

Keywords

Uraemic SarcopeniaSarcopenic Obesity

Outcome Measures

Primary Outcomes (1)

  • Presence of sacropenia

    Definition and diagnosis of sarcopenia from European European Working Group on Sarcopenia based on 1. Low muscle mass 2. Low muscle strength 3. Low physical performance

    one year

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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,liver cirrhosis, and chronic use of any type of immunosuppressive medication are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Mei-An Pai, MD

    Tungs' Taichung Metroharbour Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 24, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 17, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share