The Effects of Ethanol on Intestinal Permeability and Gut Hormones

The Effects of Orally Ethanol vs. Isoethanolaemic i.v. Infusion of Ethanol on Intestinal Permeability and Gut Hormones

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.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance; Ethanol; Incretin Effect
• Intervention / Treatment: Other: Ethanol

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral day; Participant receive ethanol orally	Other: Ethanol; The intervention is two different administrationforms of ethanol, orally and i.v.
Experimental: i.v. infusion day; Participant receive ethanol in an i.v. infusion	Other: Ethanol; The intervention is two different administrationforms of ethanol, orally and i.v.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum insulin level	difference in serum insulin level between the two administration forms	2 month

Collaborators and Investigators

• Sponsor: University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): November 20, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Incretin effect; Ethanol
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol
• Other Study ID Numbers: AlcoGut

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No