Clincosm LogoSign in Get a demo

ROSMET: Metabolic Effects of One-weak Heavy Drinking

Sponsor
University Hospital, Gentofte, Copenhagen (Other)
Overall Status
Completed
CT.gov ID
NCT04229550
Collaborator
(none)
28
Enrollment
2
Arms
1.1
Actual Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Festival participation
 N/A

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

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Metabolic Effects of One-Week Heavy Drinking and Fast Food Intake During Roskilde Festival in Young Healthy Male Adults
Actual Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Jul 4, 2016
Actual Study Completion Date :
Jul 4, 2016

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control subjects

1 week of normal daily life and only by the National Health Board recommendated alcohol consumption.
Experimental: Festival subjects

1 week's participation in Roskilde Festival 2016

Behavioral: Festival participation
One week's participation in Roskilde Festival 2016 or living a normal daily life.

Outcome Measures

Primary Outcome Measures

  1. Impairment of glucose tolerance [First day after intervention week]

    Evaluated by OGTT

Secondary Outcome Measures

  1. Hepatic steatosis [First day after intervention week]

    Evaluated by abdominal ultrasound scan

Other Outcome Measures

  1. Altered cognitive function [First day after intervention week]

    Evaluated by validated cognitive test ("SCIP")

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Gentofte, Copenhagen

Investigators

  • Principal Investigator: Filip K Knop, Prof,MD,PhD, University of Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Filip Krag Knop, Professor, MD, PhD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT04229550
Other Study ID Numbers:
  • H-15019685
First Posted:
Jan 18, 2020
Last Update Posted:
Jan 18, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Glucose Intolerance

Study Results

No Results Posted as of Jan 18, 2020