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The Effects of Ethanol on Intestinal Permeability and Gut Hormones

NCT ID: NCT03348371

Last Updated: 2017-11-20

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2017-10-01

Brief Summary

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The aime of this study is to envsitigate if ethanol has an incretin effect. This is done by administration of ethanol orally vs. an isoethanolaemic i.v. infusion of ethanol.

Detailed Description

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Conditions

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Insulin Resistance Ethanol Incretin Effect

Keywords

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Incretin effect Ethanol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Oral day

Participant receive ethanol orally

Group Type EXPERIMENTAL

Ethanol

Intervention Type OTHER

The intervention is two different administrationforms of ethanol, orally and i.v.

i.v. infusion day

Participant receive ethanol in an i.v. infusion

Group Type EXPERIMENTAL

Ethanol

Intervention Type OTHER

The intervention is two different administrationforms of ethanol, orally and i.v.

Interventions

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Ethanol

The intervention is two different administrationforms of ethanol, orally and i.v.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Caucasian male between 20 and 50 years of age
* Body mass index (BMI) between 19 and 25 kg/m2
* Weekly alcohol intake of less than 14 units of alcohol (of 12 g)
* Normal fasting plasma glucose concentration (i.e. \<6 mmol/l) and normal glycated haemoglobin A1c (HbA1c) (i.e. ≤42 mmol/mol)
* Normal haemoglobin
* Informed consent

Exclusion Criteria

* First-degree relatives with diabetes and/or liver disease
* Liver disease or other alcohol-related diseases, diabetes mellitus
* Liver disease (serum ALAT and/or serum ASAT \>2 × normal values)
* Nephropathy (serum creatinine above normal range and/or albuminuria)
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Amalie Lanng

BA

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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AlcoGut

Identifier Type: -

Identifier Source: org_study_id