HealthyNCT01303848
Circadian Rhythm of Blood Lactate
An observational study of Healthy, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial summary
To elucidate whether blood lactate, lipid transfer proteins and PPARs/CLOCK/Bal1 have a circadian rhythm Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Blood Sampling
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to May 2012
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 30 healthy probands
Who may be able to join
- Age between 18 and 40 years old
Who cannot join
- Inability/unwilling to give written informed consent
- Chronic disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Clinic Halle, Martin Luther-University Halle-Wittenberg
Halle, 06120
About this study
Official title: Circadian Rhythm of Blood Lactate, Lipid Transferproteins and Genetic Markers (PPARs, CLOCK, Bmal1)
To elucidate whether blood lactate, lipid transfer proteins and PPARs/CLOCK/Bal1 have a circadian rhythm
Read the detailed description
Blood will be drawn fasting and then every hour over a period of 24 hours in 30 healthy probands.
- Conditions
- Healthy
- Being tested
- Blood Sampling
- Keywords
- Blood lactate, Lipid transfer proteins, Lactate, PLTP, CETP, PPARs, CLOCk, Bal1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SamplingOther
Blood Sampling over 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Healthy probands | Healthy probands, age between 18 and 40 years Receives: Other: Blood Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circadian rhythm of blood lactate
Blood samples
Measured: 5 months
Secondary outcomes (2)
Circadian rhythm of Lipid transfer proteins
Blood
Measured: 5 months
Circadian rhythm of PPARs, CLOCK and Bal1
Blood
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Collaborators
- State University of New York - Downstate Medical Center
- Responsible party
- Principal investigator, Axel Schlitt, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Axel Schlitt, MD, Principal investigator, Department of Medicine III, University Clinic Halle, Martin Luther-University Halle-Wittenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303848
- Sponsor's protocol ID
- UKH2011Sport1
- Status last verified
- May 2012
- First submitted
- 24 Feb 2011
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Rhythm of Blood Lactate, Lipid Transferproteins and Genetic Markers (PPARs, CLOCK, Bmal1)
- ClinicalTrials.gov ID
- NCT01303848
- Acronym / sponsor ID
- UKH2011Sport1
- Conditions
- Healthy
- Keywords
- Blood lactate, Lipid transfer proteins, Lactate, PLTP, CETP, PPARs, CLOCk, Bal1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Collaborators
- State University of New York - Downstate Medical Center
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 Feb 2011 (estimated)
- 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.
To elucidate whether blood lactate, lipid transfer proteins and PPARs/CLOCK/Bal1 have a circadian rhythm
Detailed description
Blood will be drawn fasting and then every hour over a period of 24 hours in 30 healthy probands.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy probands | – | Other: Blood SamplingHealthy probands, age between 18 and 40 years |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 30 healthy probands
Key inclusion criteria (1 listed)
- Age between 18 and 40 years old
Key exclusion criteria (2 listed)
- Inability/unwilling to give written informed consent
- Chronic disease
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 Sampling over 24 hours | Other | Healthy probands |
Primary outcome
Circadian rhythm of blood lactate
Time frame: 5 months
Blood samples
2 secondary outcomes
Circadian rhythm of Lipid transfer proteins
Time frame: 5 months
Circadian rhythm of PPARs, CLOCK and Bal1
Time frame: 5 months
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 2 May 2012.
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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.
Axel Schlitt, MD principal investigator
Department of Medicine III, University Clinic Halle, Martin Luther-University Halle-Wittenberg
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 Healthy, run by Martin-Luther-Universität Halle-Wittenberg 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 1 inclusion and 2 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 2 May 2012. 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?
Circadian rhythm of blood lactate (time frame: 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 2 May 2012.