The Effects of Ethanol on Intestinal Permeability and Gut Hormones

Not Applicable

Completed

• Conditions: Incretin Effect; Insulin Resistance; Ethanol
• Interventions: Other: Ethanol

• Registration Number: NCT03348371
• Lead Sponsor: University of Copenhagen

Brief Summary

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

Not available

Study Timeline

• Study Start: 2016-08-01
• Primary Completion: 2017-10-01
• Study Completion: 2017-10-01
• Status Verified: 2017-11
• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2017-11-16
• Last Update Submitted: 2017-11-16
• Study First Posted: 2017-11-20
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oral day	Ethanol	Participant receive ethanol orally
i.v. infusion day	Ethanol	Participant receive ethanol in an i.v. infusion

Primary Outcome Measures

Name	Time	Method
Serum insulin level	2 month	difference in serum insulin level between the two administration forms