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The Effects of Ethanol on Intestinal Permeability and Gut Hormones

Primary Purpose

Insulin Resistance, Ethanol, Incretin Effect

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ethanol
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insulin Resistance focused on measuring Incretin effect, Ethanol

Eligibility Criteria

20 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Oral day

    i.v. infusion day

    Arm Description

    Participant receive ethanol orally

    Participant receive ethanol in an i.v. infusion

    Outcomes

    Primary Outcome Measures

    Serum insulin level
    difference in serum insulin level between the two administration forms

    Secondary Outcome Measures

    Full Information

    First Posted
    November 16, 2017
    Last Updated
    November 16, 2017
    Sponsor
    University of Copenhagen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03348371
    Brief Title
    The Effects of Ethanol on Intestinal Permeability and Gut Hormones
    Official Title
    The Effects of Orally Ethanol vs. Isoethanolaemic i.v. Infusion of Ethanol on Intestinal Permeability and Gut Hormones
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2016 (Actual)
    Primary Completion Date
    October 1, 2017 (Actual)
    Study Completion Date
    October 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Copenhagen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insulin Resistance, Ethanol, Incretin Effect
    Keywords
    Incretin effect, Ethanol

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Oral day
    Arm Type
    Experimental
    Arm Description
    Participant receive ethanol orally
    Arm Title
    i.v. infusion day
    Arm Type
    Experimental
    Arm Description
    Participant receive ethanol in an i.v. infusion
    Intervention Type
    Other
    Intervention Name(s)
    Ethanol
    Intervention Description
    The intervention is two different administrationforms of ethanol, orally and i.v.
    Primary Outcome Measure Information:
    Title
    Serum insulin level
    Description
    difference in serum insulin level between the two administration forms
    Time Frame
    2 month

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Effects of Ethanol on Intestinal Permeability and Gut Hormones

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