Metabolic DisturbanceROSMETNCT04229550
Metabolic Effects of One-weak Heavy Drinking
A study testing Festival participation in people with Metabolic Disturbance and Alcohol; Harmful Use, run by University Hospital, Gentofte, Copenhagen.
Trial summary
Examination of the effect of one week's unhealthy lifestyle on glucose metabolism and liver parameters in a group of young, healthy males participating in Roskilde Festival 2016. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disturbance, Alcohol; Harmful Use, Glucose Intolerance
- What is being tested?
- Festival participation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 4 Jul 2016
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI of 18,5-25 kg/m2
- Normal liver function (assessed by ASAT, ALAT, GGT, alkaline phosphatase, albumin and bilirubin, coagulation factors II, VII and X, INR and platelets)
Who cannot join
- Planning alcohol withdrawal or dieting/a special low-fat diet during Roskilde Festival
- Diabetes or pre-diabetes
- First degree relatives with diabetes
- Kidney disease (eGFT<60 ml/min and/or albuminuria)
- Chronic diseases (in addition to those already mentioned) that could affect participation in festival activities (concerts and parties)
- Any condition in which the investigator believed would make it impossible to participate
About this study
Official title: Metabolic Effects of One-Week Heavy Drinking and Fast Food Intake During Roskilde Festival in Young Healthy Male Adults
Examination of the effect of one week's unhealthy lifestyle on glucose metabolism and liver parameters in a group of young, healthy males participating in Roskilde Festival 2016.
Read the detailed description
Metabolic effects of intermittent unhealthy lifestyle in otherwise young healthy adults are poorly studied. The investigators evaluated the effect of one week's unhealthy lifestyle on glucose metabolism and liver parameters in a group of young, healthy males participating in Roskilde Festival 2016.
Festival participants were studied before and after participation (one week) in Roskilde Festival 2016 and matched with controls who lead a normal life for an equivalent period of time. An oral glucose tolerance test (OGTT), abdominal ultrasound and strain elastography for liver stiffness were performed together with a bioimpedance scan and cognitive tests.
- Being tested
- Festival participation
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Festival participationBehavioural
One week's participation in Roskilde Festival 2016 or living a normal daily life.
| Study group | Role | What they receive |
|---|---|---|
| Control subjects | No intervention | 1 week of normal daily life and only by the National Health Board recommendated alcohol consumption. |
| Festival subjects | Experimental | 1 week's participation in Roskilde Festival 2016 Receives: Behavioral: Festival participation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impairment of glucose tolerance
Evaluated by OGTT
Measured: First day after intervention week
Secondary outcomes (1)
Hepatic steatosis
Evaluated by abdominal ultrasound scan
Measured: First day after intervention week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Jun 2016
- Primary completion4 Jul 2016
- Study completion4 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DisturbanceStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Krag Knop, University Hospital, Gentofte, Copenhagen
- Investigators
- Filip K Knop, Prof,MD,PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229550
- Sponsor's protocol ID
- H-15019685
- Acronym
- ROSMET
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of One-Week Heavy Drinking and Fast Food Intake During Roskilde Festival in Young Healthy Male Adults
- ClinicalTrials.gov ID
- NCT04229550
- Acronym / sponsor ID
- ROSMET / H-15019685
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 4 Jul 2016 (actual)
- Study completion
- 4 Jul 2016 (actual)
- First posted
- 18 Jan 2020 (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.
Examination of the effect of one week's unhealthy lifestyle on glucose metabolism and liver parameters in a group of young, healthy males participating in Roskilde Festival 2016.
Detailed description
Metabolic effects of intermittent unhealthy lifestyle in otherwise young healthy adults are poorly studied. The investigators evaluated the effect of one week's unhealthy lifestyle on glucose metabolism and liver parameters in a group of young, healthy males participating in Roskilde Festival 2016.
Festival participants were studied before and after participation (one week) in Roskilde Festival 2016 and matched with controls who lead a normal life for an equivalent period of time. An oral glucose tolerance test (OGTT), abdominal ultrasound and strain elastography for liver stiffness were performed together with a bioimpedance scan and cognitive tests.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control subjects | No intervention | –1 week of normal daily life and only by the National Health Board recommendated alcohol consumption. |
| Festival subjects | Experimental | Behavioral: Festival participation1 week's participation in Roskilde Festival 2016 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI of 18,5-25 kg/m2
- Normal liver function (assessed by ASAT, ALAT, GGT, alkaline phosphatase, albumin and bilirubin, coagulation factors II, VII and X, INR and platelets)
Key exclusion criteria (6 listed)
- Planning alcohol withdrawal or dieting/a special low-fat diet during Roskilde Festival
- Diabetes or pre-diabetes
- First degree relatives with diabetes
- Kidney disease (eGFT<60 ml/min and/or albuminuria)
- Chronic diseases (in addition to those already mentioned) that could affect participation in festival activities (concerts and parties)
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 |
|---|---|---|
| Festival participationOne week's participation in Roskilde Festival 2016 or living a normal daily life. | Behavioural | Festival subjects |
Primary outcome
Impairment of glucose tolerance
Time frame: First day after intervention week
Evaluated by OGTT
1 secondary outcome
Hepatic steatosis
Time frame: First day after intervention week
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 18 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Filip K Knop, Prof,MD,PhD principal investigator
University of Copenhagen
Questions about this trial
What is this clinical trial studying?
A study testing Festival participation in people with Metabolic Disturbance and Alcohol; Harmful Use, run by University Hospital, Gentofte, Copenhagen.
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 2 inclusion and 6 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Impairment of glucose tolerance (time frame: First day after intervention week). 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 18 Jan 2020.