Fatty Acid MetabolismNCT03857984
Hemodialysis and Erythrocyte Fatty-Acid Status: a Lipidomics Study
A study testing Blood sampling in people with Fatty Acid Metabolism and Erythrocytes, run by Benjamin Gollasch at 1 site in Germany.
Trial summary
Hypotension with potentially serious consequences for organ perfusion is a common complication in extracorporeal procedures such as hemodialysis / hemofiltration. The exact reasons for this are still insufficiently clarified. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatty Acid Metabolism, Erythrocytes, Lipidomics
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2018to 1 Feb 2022
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who have a history of renal failure and undergo hemodialysis / hemofiltration
- Age over 18 years
- Ability to consent
- There is a written consent of the study participant
Who cannot join
- chronic illness requiring any medication
- pregnancy
- limitations regarding functioning in the hypoxic chamber
- inability to follow simple instructions relevant or severe abnormalities in medical history, physical examination
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité University Experimental & Clinical Research Center
Berlin, 13125
About this study
Hypotension with potentially serious consequences for organ perfusion is a common complication in extracorporeal procedures such as hemodialysis / hemofiltration. The exact reasons for this are still insufficiently clarified. Probably periinterventional vasorelaxant released substances play a crucial role in these procedures. These substances could be due to contact of blood cells with the Membrane in the dialyzer / hemofilter arise. In this project the hypothesis will be checked, if EETs / DHETs are released by Erythrocytes during hemodialysis and thus act as potential candidate products for the result of hypotonic phases in the Dialysis.
We will determine differences in RBC fatty acids profiling in hemodialysis patients before and after dialysis intervention. Furthermore a matched control group of healthy individuals will be profiled. RBC fatty acids profiling will be achieved by using targeted HPLC-MS mass spectrometry.
It is believed that during hemodialysis / HLM / CVVH there is an increase in EETs / DHETs in the serum and in the erythrocytes. It is believed that shear forces play an important role in the release of erythrocyte EETs / DHETs.
Read the detailed description
Differences in Erythrocyte Fatty-Acid Status Profiling in:
- before and after hemodialysis intervention
- in hemodialysis patients and healthy individuals Venous blood will be collected from each subject in the sitting position
- Conditions
- Fatty Acid Metabolism, Erythrocytes, Lipidomics, Hemodialysis
- Being tested
- Blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
blood sample before and after a single HD
| Study group | Role | What they receive |
|---|---|---|
| Erythrocyte Fatty-Acid Status | Experimental | Erythrocyte Fatty-Acid Status Profiling of HD patients are studied before and after a single HD using LC-MS / MS Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficient of variation of relative quantities of erythrocyte fatty-acid parameters related to its dynamic during Hemodialysis, using LC-MS / MS.
EETs / DHETs will be analyzed in the erythrocytes and serum of the recovered blood samples.
The determination will made in cooperation with a Berliner Biotech company. This involves liquid chromatography with MS coupling (LC-MS / MS) used. The data analysis is carried out by means of suitable statistical methods to perform erythrocyte fatty-acid status profiling.
Measured: 4-5 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start1 May 2018
- Primary completion1 Jan 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Acid MetabolismStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benjamin Gollasch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Benjamin Gollasch, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857984
- Sponsor's protocol ID
- E2/113/08
- Status last verified
- Mar 2022
- First submitted
- 24 Feb 2019
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodialysis and Erythrocyte Fatty-Acid Status: a Lipidomics Study
- ClinicalTrials.gov ID
- NCT03857984
- Acronym / sponsor ID
- E2/113/08
- Conditions
- Fatty Acid Metabolism, Erythrocytes, Lipidomics, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Benjamin GollaschUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 28 Feb 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.
Hypotension with potentially serious consequences for organ perfusion is a common complication in extracorporeal procedures such as hemodialysis / hemofiltration. The exact reasons for this are still insufficiently clarified. Probably periinterventional vasorelaxant released substances play a crucial role in these procedures. These substances could be due to contact of blood cells with the Membrane in the dialyzer / hemofilter arise. In this project the hypothesis will be checked, if EETs / DHETs are released by Erythrocytes during hemodialysis and thus act as potential candidate products for the result of hypotonic phases in the Dialysis.
We will determine differences in RBC fatty acids profiling in hemodialysis patients before and after dialysis intervention. Furthermore a matched control group of healthy individuals will be profiled. RBC fatty acids profiling will be achieved by using targeted HPLC-MS mass spectrometry.
It is believed that during hemodialysis / HLM / CVVH there is an increase in EETs / DHETs in the serum and in the erythrocytes. It is believed that shear forces play an important role in the release of erythrocyte EETs / DHETs.
Detailed description
Differences in Erythrocyte Fatty-Acid Status Profiling in:
- before and after hemodialysis intervention
- in hemodialysis patients and healthy individuals Venous blood will be collected from each subject in the sitting position
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erythrocyte Fatty-Acid Status | Experimental | Other: Blood samplingErythrocyte Fatty-Acid Status Profiling of HD patients are studied before and after a single HD using LC-MS / MS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who have a history of renal failure and undergo hemodialysis / hemofiltration
- Age over 18 years
- Ability to consent
- There is a written consent of the study participant
Key exclusion criteria (4 listed)
- chronic illness requiring any medication
- pregnancy
- limitations regarding functioning in the hypoxic chamber
- inability to follow simple instructions relevant or severe abnormalities in medical history, physical examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingblood sample before and after a single HD | Other | Erythrocyte Fatty-Acid Status |
Primary outcome
Coefficient of variation of relative quantities of erythrocyte fatty-acid parameters related to its dynamic during Hemodialysis, using LC-MS / MS.
Time frame: 4-5 Months
EETs / DHETs will be analyzed in the erythrocytes and serum of the recovered blood samples. The determination will made in cooperation with a Berliner Biotech company. This involves liquid chromatography with MS coupling (LC-MS / MS) used. The data analysis is carried out by means of suitable statistical methods to perform erythrocyte fatty-acid status profiling.
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 10 Mar 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Fatty Acid Metabolism
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
Active, not recruitingObservational study
Guangzhou Preterm and Term Birth Cohort Study
Preterm Birth, Neurodevelopmental Disorders
Not yet recruitingPhase 2
The Effects of Glucagon on Hepatic Metabolism in People With Type 2 Diabetes After Caloric Restriction
Type2diabetes
Not yet recruiting
Study on the Mechanism of Central Obesity Induced by Sleep Restriction and the Therapeutic Effect of n-3 Polyunsaturated Fatty Acid: a Randomized, Double-blind, Placebo-controlled Trial (COSPA Study)
Sleep Deprivation
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Fatty Acid Metabolism and Erythrocytes, run by Benjamin Gollasch at 1 site in Germany.
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 4 inclusion and 4 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 10 Mar 2022. 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 Germany. 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?
Coefficient of variation of relative quantities of erythrocyte fatty-acid parameters related to its dynamic during Hemodialysis, using LC-MS / MS. (time frame: 4-5 Months). 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 10 Mar 2022.