Metabolic Effects of One-weak Heavy Drinking

NCT ID: NCT04229550

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2016-07-04

Brief Summary

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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

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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.

Conditions

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Metabolic Disturbance Alcohol; Harmful Use Glucose Intolerance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control subjects

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Festival subjects

1 week's participation in Roskilde Festival 2016

Group Type EXPERIMENTAL

Festival participation

Intervention Type BEHAVIORAL

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

Interventions

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Festival participation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Filip Krag Knop

Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Filip K Knop, Prof,MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Other Identifiers

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H-15019685

Identifier Type: -

Identifier Source: org_study_id

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