Alcohol Metabolism Modifier Adverse ReactionNCT04079023
Alcohol Metabolism After Sleeve Gastrectomy
An observational study of Alcohol Metabolism Modifier Adverse Reaction and Bariatric Surgery Candidate, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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.. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Alcohol Metabolism Modifier Adverse Reaction, Bariatric Surgery Candidate
- What is being tested?
- Sleeve Gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 30 Aug 2019
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Adult
Study population: Obese, normal drinker
Who may be able to join
- Age ≥ 21 ≤ 60 years
- BMI ≥ 35 ≤49 Kg/m2
- Candidate to LSG
- Accepts to scheduled follow-up scheme
Who cannot join
- Non-drinker
- Previous history of alcoholism
- DMTII
- Hepatic cirrhosis, Nonalcoholic steatohepatitis (NASH) or HCV hepatitis/cirrhosis
- Previous resective gastro-intestinal surgery
- Cholelithiasis
Trial locations and contacts
1 site in 1 country.
About this study
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..
Read the detailed description
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
- Being tested
- Sleeve Gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve GastrectomyProcedure or surgery
Subtotal vertical gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Sleeve Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood alcohol content (BAC)
Change in BAC after SG
Measured: 0, 6 and 12 months
urinary alcohol metabolite
change in alcohol metabolite (ethanol and acetaldehyde) after SG
Measured: 0 and 12 Months
Secondary outcomes (1)
alcohol addiction
change in alcohol preferences measured with AUDIT( Alcol Use disorders Identification TesT) test
Measured: 0, 6 and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Jan 2018
- Primary completion1 Jan 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Metabolism Modifier Adverse ReactionStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda vinicola Casal del Giglio
- Responsible party
- Principal investigator, Angelo Iossa, University of Roma La Sapienza
- Investigators
- Angelo A Iossa, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079023
- Sponsor's protocol ID
- Lasapienza2019
- Status last verified
- Sep 2019
- First submitted
- 29 Aug 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pathophysiological Evaluation of Alcohol Intake and Metabolism After Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT04079023
- Acronym / sponsor ID
- Lasapienza2019
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- Azienda vinicola Casal del Giglio
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese | – | Procedure: Sleeve Gastrectomy30 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 |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Obese, normal drinker
Key inclusion criteria (4 listed)
- Age ≥ 21 ≤ 60 years
- BMI ≥ 35 ≤49 Kg/m2
- Candidate to LSG
- Accepts to scheduled follow-up scheme
Key exclusion criteria (6 listed)
- Non-drinker
- Previous history of alcoholism
- DMTII
- Hepatic cirrhosis, Nonalcoholic steatohepatitis (NASH) or HCV hepatitis/cirrhosis
- Previous resective gastro-intestinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleeve GastrectomySubtotal vertical gastrectomy | Procedure or surgery | Obese |
Primary outcome
blood alcohol content (BAC)
Time frame: 0, 6 and 12 months
Change in BAC after SG
urinary alcohol metabolite
Time frame: 0 and 12 Months
change in alcohol metabolite (ethanol and acetaldehyde) after SG
1 secondary outcome
alcohol addiction
Time frame: 0, 6 and 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelo A Iossa principal investigator
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Metabolism Modifier Adverse Reaction and Bariatric Surgery Candidate, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood alcohol content (BAC) (time frame: 0, 6 and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.