Back to resultsMetabolic Effects of One-weak Heavy Drinking (ROSMET)
Primary Purpose
Metabolic Disturbance, Alcohol; Harmful Use, Glucose Intolerance
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Festival participation
Sponsored by
About this trial
This is an interventional other trial for Metabolic Disturbance
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control subjects
Festival subjects
Arm Description
1 week of normal daily life and only by the National Health Board recommendated alcohol consumption.
1 week's participation in Roskilde Festival 2016
Outcomes
Primary Outcome Measures
Impairment of glucose tolerance
Evaluated by OGTT
Secondary Outcome Measures
Hepatic steatosis
Evaluated by abdominal ultrasound scan
Full Information
NCT ID
NCT04229550
First Posted
January 8, 2020
Last Updated
January 12, 2020
Sponsor
University Hospital, Gentofte, Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT04229550
Brief Title
Metabolic Effects of One-weak Heavy Drinking
Acronym
ROSMET
Official Title
Metabolic Effects of One-Week Heavy Drinking and Fast Food Intake During Roskilde Festival in Young Healthy Male Adults
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
July 4, 2016 (Actual)
Study Completion Date
July 4, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disturbance, Alcohol; Harmful Use, Glucose Intolerance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control subjects
Arm Type
No Intervention
Arm Description
1 week of normal daily life and only by the National Health Board recommendated alcohol consumption.
Arm Title
Festival subjects
Arm Type
Experimental
Arm Description
1 week's participation in Roskilde Festival 2016
Intervention Type
Behavioral
Intervention Name(s)
Festival participation
Intervention Description
One week's participation in Roskilde Festival 2016 or living a normal daily life.
Primary Outcome Measure Information:
Title
Impairment of glucose tolerance
Description
Evaluated by OGTT
Time Frame
First day after intervention week
Secondary Outcome Measure Information:
Title
Hepatic steatosis
Description
Evaluated by abdominal ultrasound scan
Time Frame
First day after intervention week
Other Pre-specified Outcome Measures:
Title
Altered cognitive function
Description
Evaluated by validated cognitive test ("SCIP")
Time Frame
First day after intervention week
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filip K Knop, Prof,MD,PhD
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Metabolic Effects of One-weak Heavy Drinking
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