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Completed

NCT Number: NCT03348371

The Effects 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.

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Key information

Conditions

Insulin Resistance Ethanol Glucose Metabolism Disorders Hyperinsulinism Incretin Effect Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ethanol

Other

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

Primary outcomes

  1. Serum insulin level

    Time frame: 2 month

    difference in serum insulin level between the two administration forms

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 20, 2017
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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