AutophagyNCT03925753
Correlation Between Autophagy-related Proteins and Inflammatory Markers in Hemodialysis Patients
An observational study of Autophagy, run by Tungs' Taichung Metroharbour Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Autophagy
- How many people
- 62 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2019to 31 Dec 2019
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients have to be at least 20-years-old and on outpatient hemodialysis (HD) for at least 3 months.
Who may be able to join
- Both sexes aged between 20-90 years.
- Received stable hemodialysis at least 3 months.
- Written informed consent.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Autophagy-related Proteins in Peripheral Blood Mononuclear Cells and Inflammatory Markers in Hemodialysis Patients
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.
Read the detailed description
Study Design and Population
Study Design We shall enroll 30 healthy volunteers as the control group. 180 sex- and age-matched hemodialysis patients will be enrolled in this study. To be included in the study, patients have to be at least 20-years-old and on outpatient hemodialysis (HD) for at least 3 months. Patients are excluded if they had malignancy, severe liver disease (bilirubin >1.6 mg/dl), uncontrolled hypertension, severe obesity (BMI >35), currently on carbamazepine, statins or immunosuppressive agents. The medical record is thoroughly reviewed for each subject by a collaborating physician in the study. All subjects will provide written informed consent to participate and the protocol will be send to the institutional review boards of Tungs' Taichung Metroharbour Hospital
Study Parameters Predialysis blood samples are obtained on a mid-week day. Within 30 min after sampling, the remaining blood is centrifuged at 3,000 g for 10 min, immediately aliquoted and frozen at -80°C until further analysis.
Cytokine assays The following markers of inflammation and hemostasis are determined by ELISA in patients' sera: interleukin-6 (Quantikine, R\&D Systems,) and plasma concentrations of CRP in a highly sensitive assay (hsCRP).
Analysis of lipids/lipoproteins Total cholesterol, highdensity lipoprotein (HDL) cholesterol, and triglyceride concentrations are determined enzymatically. Plasma glucose is measured by a glucose-oxidase method.
Measurements of Liposaccharide-binding protein (LBP) The LBP was determined from serum samples and controls using standardized enzymelinked immunosorbent assay (ELISA) methods, and serum from normal control subjects was used for interassay variation.
Isolation of PBMCs Ethylenediamine tetraacetic acid Vacutainer™ tubes are used to collect venous blood samples (10 ml) from fasting participants in the early morning. Aliquots of the supernatant are collected by centrifugation at 800 x g and 25˚C for 15 min and subsequently store at -80˚C. The remaining blood is mixed and add slowly dropwise to a centrifuge tube containing 10 ml of Ficoll separation medium. PBMCs are isolated according to manufacturer's protocol and store at -80˚C.
Western blotting PBMCs are lysed with RIPA lysis buffer and protein concentrations determined with the BCA Protein Assay kit according to the manufacturer's protocol. Subsequently, 20 μg of protein/well are separated using 12% SDS-PAGE. The proteins are subsequently transferred to nitrocellulose membranes at 300 mA for 60 min. The nitrocellulose membranes are blocked with Tris-buffered saline containing 0.1% Tween 20 (TBST) and 5% non-fat milk powder for 2 h at room temperature. The nitrocellulose membranes are incubated with primary antibodies overnight at 4˚C on a shaker set at a slow speed. The nitrocellulose membranes are washed thrice with TBST and incubated with secondary antibodies for 1 h at room temperature. After washing thrice, ECL substrate is added to the nitrocellulose membrane. The signal is detected using Image Lab™ software and band density will be quantified with imager software .
The primary antibodies against microtubule-associated proteins 1A/1B light chain 3A , ubiquitin-binding protein p62 and beclin-1 as well as GAPDH will be purchased. Peroxidase-conjugated goat anti-mouse and goat anti-rabbit secondary antibodies are used.
- Conditions
- Autophagy
- Keywords
- autophagy, inflammatory markers
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of the autophagy-associated proteins ubiquitin-binding protein p62 (p62)
ubiquitin-binding protein p62 (p62) in PBMCs will be detected by western blotting.
Measured: 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.
Measured: 1 years
Levels of the autophagy-associated proteins beclin-1
beclin-1 in PBMCs will be detected by western blotting.
Measured: 1 years
Secondary outcomes (3)
Analysis of biomarkers of Liposaccharide-binding protein (LBP)
The LBP was determined from serum samples and controls using standardized enzymelinked immunosorbent assay (ELISA) methods
Measured: 1 years
Analysis of biomarkers of IL-6
The IL-6 was determined from serum samples and controls using standardized enzymelinked immunosorbent assay (ELISA) methods was determined from serum samples and controls using standardized enzymelinked immunosorbent assay (ELISA) methods
Measured: 1 years
Measurements of TNF-α
The TNF-α was determined from serum samples and controls using standardized enzymelinked immunosorbent assay (ELISA) methods
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start1 Mar 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutophagyStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tungs' Taichung Metroharbour Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paik Seong Lim, PhD, Study chair, Tungs' Taichung Metroharbour Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925753
- Sponsor's protocol ID
- 107054
- Status last verified
- Jan 2021
- First submitted
- 22 Apr 2019
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Autophagy-related Proteins in Peripheral Blood Mononuclear Cells and Inflammatory Markers in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03925753
- Acronym / sponsor ID
- 107054
- Conditions
- Autophagy
- Keywords
- autophagy, inflammatory markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Tungs' Taichung Metroharbour HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Apr 2019 (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.
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.
Detailed description
Study Design and Population
Study Design We shall enroll 30 healthy volunteers as the control group. 180 sex- and age-matched hemodialysis patients will be enrolled in this study. To be included in the study, patients have to be at least 20-years-old and on outpatient hemodialysis (HD) for at least 3 months. Patients are excluded if they had malignancy, severe liver disease (bilirubin >1.6 mg/dl), uncontrolled hypertension, severe obesity (BMI >35), currently on carbamazepine, statins or immunosuppressive agents. The medical record is thoroughly reviewed for each subject by a collaborating physician in the study. All subjects will provide written informed consent to participate and the protocol will be send to the institutional review boards of Tungs' Taichung Metroharbour Hospital
Study Parameters Predialysis blood samples are obtained on a mid-week day. Within 30 min after sampling, the remaining blood is centrifuged at 3,000 g for 10 min, immediately aliquoted and frozen at -80°C until further analysis.
Cytokine assays The following markers of inflammation and hemostasis are determined by ELISA in patients' sera: interleukin-6 (Quantikine, R\&D Systems,) and plasma concentrations of CRP in a highly sensitive assay (hsCRP).
Analysis of lipids/lipoproteins Total cholesterol, highdensity lipoprotein (HDL) cholesterol, and triglyceride concentrations are determined enzymatically. Plasma glucose is measured by a glucose-oxidase method.
Measurements of Liposaccharide-binding protein (LBP) The LBP was determined from serum samples and controls using standardized enzymelinked immunosorbent assay (ELISA) methods, and serum from normal control subjects was used for interassay variation.
Isolation of PBMCs Ethylenediamine tetraacetic acid Vacutainer™ tubes are used to collect venous blood samples (10 ml) from fasting participants in the early morning. Aliquots of the supernatant are collected by centrifugation at 800 x g and 25˚C for 15 min and subsequently store at -80˚C. The remaining blood is mixed and add slowly dropwise to a centrifuge tube containing 10 ml of Ficoll separation medium. PBMCs are isolated according to manufacturer's protocol and store at -80˚C.
Western blotting PBMCs are lysed with RIPA lysis buffer and protein concentrations determined with the BCA Protein Assay kit according to the manufacturer's protocol. Subsequently, 20 μg of protein/well are separated using 12% SDS-PAGE. The proteins are subsequently transferred to nitrocellulose membranes at 300 mA for 60 min. The nitrocellulose membranes are blocked with Tris-buffered saline containing 0.1% Tween 20 (TBST) and 5% non-fat milk powder for 2 h at room temperature. The nitrocellulose membranes are incubated with primary antibodies overnight at 4˚C on a shaker set at a slow speed. The nitrocellulose membranes are washed thrice with TBST and incubated with secondary antibodies for 1 h at room temperature. After washing thrice, ECL substrate is added to the nitrocellulose membrane. The signal is detected using Image Lab™ software and band density will be quantified with imager software .
The primary antibodies against microtubule-associated proteins 1A/1B light chain 3A , ubiquitin-binding protein p62 and beclin-1 as well as GAPDH will be purchased. Peroxidase-conjugated goat anti-mouse and goat anti-rabbit secondary antibodies are used.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients have to be at least 20-years-old and on outpatient hemodialysis (HD) for at least 3 months.
Key inclusion criteria (3 listed)
- Both sexes aged between 20-90 years.
- Received stable hemodialysis at least 3 months.
- Written informed consent.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Levels of the autophagy-associated proteins ubiquitin-binding protein p62 (p62)
Time frame: 1 years
ubiquitin-binding protein p62 (p62) in PBMCs will be detected by western blotting.
Levels of the autophagy-associated proteins microtubule-associated proteins 1A/1B light chain 3A (LC3I/II)
Time frame: 1 years
microtubule-associated proteins 1A/1B light in PBMCs will be detected by western blotting.
Levels of the autophagy-associated proteins beclin-1
Time frame: 1 years
beclin-1 in PBMCs will be detected by western blotting.
3 secondary outcomes
Analysis of biomarkers of Liposaccharide-binding protein (LBP)
Time frame: 1 years
Analysis of biomarkers of IL-6
Time frame: 1 years
Measurements of TNF-α
Time frame: 1 years
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 1 Feb 2021.
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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.
Paik Seong Lim, PhD study chair
Tungs' Taichung Metroharbour Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autophagy, run by Tungs' Taichung Metroharbour Hospital at 1 site in Taiwan.
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 3 inclusion and 3 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 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Levels of the autophagy-associated proteins ubiquitin-binding protein p62 (p62) (time frame: 1 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.