Skip to main content
OpenTrials
Completed

NCT Number: NCT04079023

Alcohol Metabolism After Sleeve Gastrectomy

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..

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rome "la sapienza"

Latina, 04100, Italy

About this study

The sample size was selected based on the number of obese patients who underwent SG at our Bariatric Center of Excellence IFSO-EC over the last 12 months, and the end-time of evaluation was estimated independently due to the lack of high evidence-based studies, such as randomized trials or meta-analyses, focusing on the impact of alcohol on the bariatric population. Considering the requirement of 200 patients to obtain a 95% confidence level, a sample size of 30 patients was selected to achieve a confidence interval (margin of error) of 16.54. Data were collected and analyzed as mean and standard deviation.

Inclusion criteria

were patients aged 21-60 years with BMI of 35-49 kg/m2 who were planned to undergo primary SG and agreed to participate in the study and undergo evaluation before and after SG. Exclusion criteria were non-drinker, previous history of alcoholism, T2D diagnosed based on the ADA criteria for diabetes 2016, hepatic cirrhosis, nonalcoholic steatohepatitis or hepatitis C/cirrhosis, previous resective gastrointestinal surgery (elective or emergent), previous bariatric procedures, and cholelithiasis (symptomatic or asymptomatic).

The amount of wine to be consumed was calculated based on the patient's total water body mass at the time of measurement (0-6-12 months) because alcohol is distributed throughout the entire water body mass without adhering to plasma proteins and its solubility in fat and bones is undetectable. The amount of wine (mL) was calculated using the following formula reported by Maluenda et al.: 3.6 × total body water (TBW). Body mass composition was measured using BIA 101 ASE (Akern SRL, Firenze, Italy) after 2-h fasting and emptying the bladder and analyzed using the Bodygram Plus software V.1.0 (Akern SRL, Firenze, Italy). The red wine Madreselva containing 14% of alcohol per liter, which is certified for standard alcohol level at packaging and durability of over 3 years, was kindly provided by the local factory Casal del Giglio. At time 0, BAC was measured using an ethanol assay kit (DiaSys Diagnostic Systems GmbH) at 15, 30, and 60 mins and then every 30 min after alcohol intake until the ethanol level of 0 g/L was obtained. Six hours of fasting before and after wine consumption were observed. Blood examination was repeated at 6 and 12 months after SG. At time 0 and 12 months after SG, the urinary metabolite (ethanol and acetaldehyde) levels were evaluated after urinary bladder filling for 2 h and the liver function [albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), bilirubin, lactate dehydrogenase (LD), alkaline phosphatase (ALP), uric acid, and INR] was evaluated to detect alcohol-induced changes. Each patient's subjective attitude to alcohol consumption was evaluated at 0- and 12-months using alcohol use disorder identification test (AUDIT); score ≥ 8 was considered to indicate alcohol dependence and those patients were excluded as per the study criteria. The perception of symptoms, including the most common symptoms of alcoholization (euphoria and diaphoresis) and intoxication (anxiety, nausea/vomiting, and flushing), after alcohol consumption was evaluated using a newly developed symptom alcoholization post obesity surgery (SAPoS) scoring system (not validated). This scoring system was created based on the experience gained during clinical check-ups and investigates the symptoms occurring after alcohol consumption. The data on BAC at 0-6-12 months, urinary metabolite levels at 0-12 months, and SAPoS scores at 0-6-12 months were compared. Differences were considered statistically significant at p < 0.05

Who can participate

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Sleeve gastrectomy

Procedure

Subtotal vertical gastrectomy

Primary outcomes

  1. blood alcohol content (BAC)

    Time frame: 0, 6 and 12 months

    Change in BAC after SG

  2. urinary alcohol metabolite

    Time frame: 0 and 12 Months

    change in alcohol metabolite (ethanol and acetaldehyde) after SG

Secondary outcomes

  1. alcohol addiction

    Time frame: 0, 6 and 12 Months

    change in alcohol preferences measured with AUDIT( Alcol Use disorders Identification TesT) test

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Collaborators

  • Azienda vinicola Casal del Giglio

Registry information

Official study title

Prospective Pathophysiological Evaluation of Alcohol Intake and Metabolism After Sleeve Gastrectomy

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 6, 2019
Registry last updated
Sep 6, 2019

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.

Published trials that share one or more normalized conditions with this study.