The Effects of Ethanol on Intestinal Permeability and Gut Hormones

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03348371
• Other study ID #: AlcoGut
• Status: Completed
• Phase: N/A
• First received: November 16, 2017
• Last updated: November 16, 2017
• Start date: August 1, 2016
• Est. completion date: October 1, 2017

Study information

• Verified date: November 2017
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ethanol
• Incretin Effect
• Insulin Resistance

Intervention

Other:
• Ethanol
The intervention is two different administrationforms of ethanol, orally and i.v.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum insulin level	difference in serum insulin level between the two administration forms	2 month