NCT02718586

Brief Summary

The aim is to test if serum level of myokines are associated with protein energy wasting, inflammation and atherosclerotic vascular disease among Taiwanese dialysis patients. Some novel myokines levels, anthropometric parameters, cardiovascular risk factors, and presence of endothelial dysfunction will be examined in 250 subjects. The distribution of some recently identified myokines such as irisin, myotatin etc levels will be studied and correlated markers of malnutrition, endothelial dysfunction, inflammation and insulin resistance. In the present study, the investigators will further follow and investigate whether serum myokines levels are associated with long-term mortality from all causes and from cardiovascular disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 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

Protein-energy; Imbalance

Keywords

MyokinesProtein Energy WastingHemodialysis

Outcome Measures

Primary Outcomes (1)

  • Presence of protein energy wasting

    According to the diagnostic criteria for PEW proposed by ISRNM

    1 year

Eligibility Criteria

Age20 Years - 70 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 between 20-70 years.
  • Received stable hemodialysis at least 3 months.
  • Written informed consent.

You may not qualify if:

  • Patients with malignant disease, acute infectious disease, inflammatory disease (such as collagen disease), advanced liver disease, and those taking any type of immunosuppressive medication are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

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