NCT03925753

Brief Summary

One recent study demonstrated impaired autophagy in patients receiving hemodialysis (HD). To clarify whether this alteration is related to the inflammatory state in HD patients, we focused on basal autophagy in peripheral blood mononuclear cells (PBMCs) of HD patients with and without inflammation and controls. PBMCs were harvested using Ficoll density gradient centrifugation . Levels of the autophagy-associated proteins ubiquitin-binding protein p62 (p62), microtubule-associated proteins 1A/1B light chain 3A (LC3I/II) and beclin-1 in PBMCs will be detected by western blotting. Enzyme-linked immunosorbent assay kits will be used to detect the serum concentrations of interleukin (IL)-6, liposaccharide-binding protein (LBP) and tumor necrosis factor (TNF)-α.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

10 months

First QC Date

April 22, 2019

Last Update Submit

January 29, 2021

Conditions

Keywords

autophagyinflammatory markers

Outcome Measures

Primary Outcomes (3)

  • Levels of the autophagy-associated proteins ubiquitin-binding protein p62 (p62)

    ubiquitin-binding protein p62 (p62) in PBMCs will be detected by western blotting.

    1 years

  • Levels of the autophagy-associated proteins microtubule-associated proteins 1A/1B light chain 3A (LC3I/II)

    microtubule-associated proteins 1A/1B light in PBMCs will be detected by western blotting.

    1 years

  • Levels of the autophagy-associated proteins beclin-1

    beclin-1 in PBMCs will be detected by western blotting.

    1 years

Secondary Outcomes (3)

  • Analysis of biomarkers of Liposaccharide-binding protein (LBP)

    1 years

  • Analysis of biomarkers of IL-6

    1 years

  • Measurements of TNF-α

    1 years

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients have to be at least 20-years-old and on outpatient hemodialysis (HD) for at least 3 months.

You may qualify if:

  • Both sexes aged between 20-90 years.
  • Received stable hemodialysis at least 3 months.
  • Written informed consent.

You may not qualify if:

  • patients with severe infections, severe heart disease and liver disease, malignancy, autoimmune disorders, severe malnutrition, or clinical conditions requiring oral nutrition supplements;
  • Inability to follow protocol.
  • Pregnancy or wishing/trying to get pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tungs' Taichung MetroHarbour Hospital

Taichung, Taiwan

Location

Study Officials

  • Paik Seong Lim, PhD

    Tungs' Taichung Metroharbour Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2019

First Posted

April 24, 2019

Study Start

March 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations