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Completed

NCT Number: NCT04229550

Metabolic Effects of One-weak Heavy Drinking

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.

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Key information

Conditions

Metabolic Disturbance Alcohol; Harmful Use Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Festival participation

Behavioral

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

Primary outcomes

  1. Impairment of glucose tolerance

    Time frame: First day after intervention week

    Evaluated by OGTT

Secondary outcomes

  1. Hepatic steatosis

    Time frame: First day after intervention week

    Evaluated by abdominal ultrasound scan

Other outcomes

  1. Altered cognitive function

    Time frame: First day after intervention week

    Evaluated by validated cognitive test ("SCIP")

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

Metabolic Effects of One-Week Heavy Drinking and Fast Food Intake During Roskilde Festival in Young Healthy Male Adults

Acronym: ROSMET

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 18, 2020
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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