NCT04079023

Brief Summary

This prospective study aimed to determine the alcohol intake symptoms and alcohol metabolism before and 12 months after sleeve gastrectomy (SG) by evaluating blood alcohol content (BAC) and urinary alcohol metabolite levels against the amount of alcohol consumed to reveal the occurrence of any AUD..

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

August 29, 2019

Last Update Submit

September 4, 2019

Conditions

Alcohol Metabolism Modifier Adverse ReactionBariatric Surgery Candidate

Outcome Measures

Primary Outcomes (2)

  • blood alcohol content (BAC)

    Change in BAC after SG

    0, 6 and 12 months

  • urinary alcohol metabolite

    change in alcohol metabolite (ethanol and acetaldehyde) after SG

    0 and 12 Months

Secondary Outcomes (1)

  • alcohol addiction

    0, 6 and 12 Months

Study Arms (1)

Obese

30 obese patients (12 M/ 18 F) with a mean BMI of 46 candidate to SG Alcohol drink mean volume: 158 Ml administered in 10 minutes

Procedure: Sleeve Gastrectomy

Interventions

Sleeve GastrectomyPROCEDURE

Subtotal vertical gastrectomy

Obese

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Obese, normal drinker

You may qualify if:

  • Age ≥ 21 ≤ 60 years
  • BMI ≥ 35 ≤49 Kg/m2
  • Candidate to LSG
  • Accepts to scheduled follow-up scheme

You may not qualify if:

  • Non-drinker
  • Previous history of alcoholism
  • DMTII
  • Hepatic cirrhosis, Nonalcoholic steatohepatitis (NASH) or HCV hepatitis/cirrhosis
  • Previous resective gastro-intestinal surgery
  • Cholelithiasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rome "la sapienza"

Latina, 04100, Italy

Location

Study Officials

  • Angelo A Iossa

    University of Roma La Sapienza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 29, 2019

First Posted

September 6, 2019

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

August 30, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)