NCT03348371

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

November 16, 2017

Last Update Submit

November 16, 2017

Conditions

Insulin ResistanceEthanolIncretin Effect

Keywords

Incretin effectEthanol

Outcome Measures

Primary Outcomes (1)

  • Serum insulin level

    difference in serum insulin level between the two administration forms

    2 month

Study Arms (2)

Oral day

EXPERIMENTAL

Participant receive ethanol orally

Other: Ethanol

i.v. infusion day

EXPERIMENTAL

Participant receive ethanol in an i.v. infusion

Other: Ethanol

Interventions

EthanolOTHER

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

Oral dayi.v. infusion day

Eligibility Criteria

Age20 Years - 50 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Insulin Resistance

Interventions

Ethanol

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BA

Study Record Dates

First Submitted

November 16, 2017

First Posted

November 20, 2017

Study Start

August 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

November 20, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share