Bariatric Surgery Candidate Clinical Trial
Official title:
Prospective Pathophysiological Evaluation of Alcohol Intake and 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..
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
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