Healthy AdultsCoMealNCT01772914
Copeptin Changes After Food Intake
An observational study of Healthy Adults and Copeptin, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine whether copeptin levels are affected by food intake. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults, Copeptin
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2013to Feb 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy adults
Who may be able to join
- Aged over 18 years
Who cannot join
- Intake of any kind of medication (except birth control pill)
- BMI >30 kg/m2
- Evidence of any acute illness
- History of chronic illness
- Pregnancy
- Known galactosemia or maltose malabsorption
- Baseline glucose level >5.5 mmol/l Baseline sodium level <135 mmol/l or >145 mmol/l
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Copeptin During a Standardized Oral Glucose Tolerance Test and a Mixed Meal Tolerance Test
The purpose of this study is to determine whether copeptin levels are affected by food intake.
- Conditions
- Healthy Adults, Copeptin
- Keywords
- Copeptin, eating, glucose tolerance test, mixed meal test, physiological
- Medical subject headings
- Diabetes Insipidus
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in copeptin levels after intake of a oral glucose tolerance test- and a mixed meal tolerance test liquid
Measured: 30, 60, 90, 120, 180 minutes after intake of the test liquids
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultsStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirjam Christ-Crain, University Hospital, Basel, Switzerland
- Investigators
- Mirjam Christ-Crain, Prof.Dr.med., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772914
- Sponsor's protocol ID
- CoMeal 2013
- Acronym
- CoMeal
- Status last verified
- Jan 2013
- First submitted
- 17 Jan 2013
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Walti C, Siegenthaler J, Christ-Crain M. Copeptin levels are independent of ingested nutrient type after standardised meal administration--the CoMEAL study. Biomarkers. 2014 Nov;19(7):557-62. doi: 10.3109/1354750X.2014.940504. Epub 2014 Sep 16.
PubMed 25224842
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Copeptin During a Standardized Oral Glucose Tolerance Test and a Mixed Meal Tolerance Test
- ClinicalTrials.gov ID
- NCT01772914
- Acronym / sponsor ID
- CoMeal / CoMeal 2013
- Conditions
- Healthy Adults, Copeptin
- Keywords
- Copeptin, eating, glucose tolerance test, mixed meal test, physiological
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 Jan 2013 (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.
The purpose of this study is to determine whether copeptin levels are affected by food intake.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy adults
Key inclusion criteria (1 listed)
- Aged over 18 years
Key exclusion criteria (7 listed)
- Intake of any kind of medication (except birth control pill)
- BMI >30 kg/m2
- Evidence of any acute illness
- History of chronic illness
- Pregnancy
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
Changes in copeptin levels after intake of a oral glucose tolerance test- and a mixed meal tolerance test liquid
Time frame: 30, 60, 90, 120, 180 minutes after intake of the test liquids
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 20 May 2014.
- Derived from this study: PubMed 25224842Walti C, Siegenthaler J, Christ-Crain M. Copeptin levels are independent of ingested nutrient type after standardised meal administration--the CoMEAL study. Biomarkers. 2014 Nov;19(7):557-62. doi: 10.3109/1354750X.2014.940504. Epub 2014 Sep 16.
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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.
Mirjam Christ-Crain, Prof.Dr.med. principal investigator
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 Adults and Copeptin, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 7 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 20 May 2014. 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 Switzerland. 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?
Changes in copeptin levels after intake of a oral glucose tolerance test- and a mixed meal tolerance test liquid (time frame: 30, 60, 90, 120, 180 minutes after intake of the test liquids). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01772914, which also lists 1 linked publication.
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 20 May 2014.