Integrative Human PhysiologyNCT04048993
Registry-based Biobank Development and Integrative Physiological Analysis
An observational study of Integrative Human Physiology, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The purpose is to develop a registry-based biobank for integrative physiological analysis based on biological samples (blood, urine, interstitial fluid and muscle) from subjects enrolled in the Section registry, using multivariate and data-mining approaches that includes also clinical and demographic parameters Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Integrative Human Physiology
- What is being tested?
- Biobank development and integrative physiological analysis
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2019to 10 Aug 2028
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Human subjects able to perform exercise
Who may be able to join
- able to perform fatiguing exercise
Who cannot join
- severe mental or physical handicap
- chronic disease deemed by the M.D. to preclude inclusion
- use of prescription medicine deemed by the M.D. to preclude inclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
University of Copenhagen
Copenhagen, 2100
Morten Hostrup, PhD, 24474785, mhostrup@nexs.ku.dk
About this study
The purpose is to develop a registry-based biobank for integrative physiological analysis based on biological samples (blood, urine, interstitial fluid and muscle) from subjects enrolled in the Section registry, using multivariate and data-mining approaches that includes also clinical and demographic parameters
- Conditions
- Integrative Human Physiology
- Being tested
- Biobank development and integrative physiological analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biobank development and integrative physiological analysisOther
Collection of biological samples (blood, urine, interstitial fluid, adipose tissue and muscle) from subjects enrolled in the Section registry, using multivariate and data-mining approaches that includes also clinical and demographic parameters.
What is being measured
The primary outcome is the main question the study is designed to answer.
Biobank creation
Collection of biological samples from subjects included in the Section Registry
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start1 Sep 2019
- Primary completion10 Aug 2028 (estimated)
- Study completion10 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Integrative Human PhysiologyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Hostrup, PhD, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048993
- Sponsor's protocol ID
- BIO
- Status last verified
- Feb 2025
- First submitted
- 5 Aug 2019
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry-based Biobank Development and Integrative Physiological Analysis
- ClinicalTrials.gov ID
- NCT04048993
- Acronym / sponsor ID
- BIO
- Conditions
- Integrative Human Physiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 10 Aug 2028 (estimated)
- Study completion
- 10 Aug 2028 (estimated)
- First posted
- 7 Aug 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.
The purpose is to develop a registry-based biobank for integrative physiological analysis based on biological samples (blood, urine, interstitial fluid and muscle) from subjects enrolled in the Section registry, using multivariate and data-mining approaches that includes also clinical and demographic parameters
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Human subjects able to perform exercise
Key inclusion criteria (1 listed)
- able to perform fatiguing exercise
Key exclusion criteria (3 listed)
- severe mental or physical handicap
- chronic disease deemed by the M.D. to preclude inclusion
- use of prescription medicine deemed by the M.D. to preclude inclusion
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 |
|---|---|---|
| Biobank development and integrative physiological analysisCollection of biological samples (blood, urine, interstitial fluid, adipose tissue and muscle) from subjects enrolled in the Section registry, using multivariate and data-mining approaches that includes also clinical and demographic parameters. | Other | – |
Primary outcome
Biobank creation
Time frame: through study completion, an average of 5 years
Collection of biological samples from subjects included in the Section Registry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: Undecided
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.
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 Integrative Human Physiology, run by University of Copenhagen at 1 site in Denmark.
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 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: looking for participants now, as of the sponsor's last update on 10 Feb 2025. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Morten Hostrup, PhD (24474785, mhostrup@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biobank creation (time frame: through study completion, an average of 5 years). 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 Feb 2025; AzTrials last refreshed its copy on 29 Oct 2026.