The Effects of Ethanol on Intestinal Permeability and Gut... | NCT03348371

Studies
The Effects of Ethanol on Intestinal Permeability and Gut Hormones

NCT03348371

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Nov 20, 2017Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Insulin Resistance
Ethanol
Incretin Effect

Interventions

Ethanol

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2016Actual

Primary Completion Date

Oct 1, 2017Actual

Completion Date

Oct 1, 2017Actual

First Submitted Date

Nov 16, 2017

First Submission Date that Met QC Criteria

Nov 16, 2017

First Posted Date

Nov 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2017

Last Update Posted Date

Nov 20, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ethanol	Other	The intervention is two different administrationforms of ethanol, orally and i.v.	Oral day i.v. infusion day

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum insulin level	difference in serum insulin level between the two administration forms	2 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000431	Ethanol

Ancestor Terms

ID	Term
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided