Morbid ObesityNCT02366624
Effect of Bariatric Surgery on Bile Acid Homeostasis
An observational study of Morbid Obesity, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The purpose of this study is to evaluate the effect of bariatric surgery in bile acid homeostasis and its interrelationship with the metabolic changes induced by the surgery. This study contemplates the following hypothesis: Bariatric Surgery induce a new study state in bile acid homeostasis with higher bile acid… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- How many people
- 104 participants
- Where
- 1 siteChile
- Study dates
- Feb 2013to Mar 2015
- How long will I take part?
- 1 Year
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Obese patients that have undergone bariatric surgery or medical treatment to lose weight.
Who may be able to join
- Male and Female, 18 to 50 years old.
- Body mass index(BMI)≥35 and <40 with comorbidities or BMI ≥40 and <45 with or without comorbidities.
- HbA1c<8%.
- Subjects willing to comply with study requirements.
Who cannot join
- Previous cholecystectomy or gallbladder stones at baseline visit.
- Previous bariatric surgery, small bowel or colon resection.
- Use of drugs:cholestyramine,colesevelam,colestilan, colestimide, colestipol,insulin,exenatide, thiazolidinedione or dipeptidyl peptidase IV(DPPIV)inhibitors, selective serotonin re uptake inhibitor antidepressants.
- Pregnancy or intent to become pregnant.
- Cardiac, renal or liver failure.
- Cancer,infection.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan
About this study
Official title: Effect of Gastric Bypass, Sleeve Gastrectomy and Duodenal-jejunal Bypass on Bile Acid Homeostasis
The purpose of this study is to evaluate the effect of bariatric surgery in bile acid homeostasis and its interrelationship with the metabolic changes induced by the surgery.
This study contemplates the following hypothesis:
- Bariatric Surgery induce a new study state in bile acid homeostasis with higher bile acid synthesis in association with increased bile acid content.
- The major effects of bariatric surgery on bile acid synthesis and is observed one month after surgery with a progressively decline during the first year of follow-up.
- Gastric bypass increases serum bile acid content, postprandial plasma bile acid response and fecal bile acid excretion.
- Serum bile acids changes induced by gastric bypass are positively correlated with changes in gastric inhibitory polypeptide (GIP) levels and postprandial concentration of insulin and glucagon like peptide-1 (GLP-1) and inversely correlated with thyrotropic hormone (TSH) and postprandial concentration of glucose.
- Changes in postprandial plasma bile acid response induced by gastric bypass positively correlates with changes in postprandial concentration of insulin, GLP-1 and peptide YY (PYY) and inversely correlates postprandial response of ghrelin and glucose.
Read the detailed description
The proposed study will be conducted in adult subjects that will undergo to gastric bypass,sleeve gastrectomy or endoscopic duodenal-jejunal bypass.
as treatment for their obesity. As a first approach (Protocol A) in each of these groups the investigators will determine 7α-hydroxy-4-cholestene -3-one (C4) levels, a marker of bile acid synthesis, and fibroblast growth factor 19 (FGF19), inhibitor of the expression of Cholesterol 7- hydroxylase (CYP7A1), prior to surgery and then at months 1, 3, 6 and 12 of postoperative follow-up. The same measurements will be performed to a group of patients under medical treatment when they achieve 10-kg diet-induced weight loss, which is equivalent to one-month of surgically induced weight loss. Preliminary studies suggest that gastric bypass induces a greater weight loss and improvement of associated disease compared with sleeve gastrectomy and endoscopic duodenal-jejunal bypass. Therefore, we expect a deeper change in bile acid homeostasis after gastric bypass, than after the other procedures. For this reason, in patients with gastric bypass the investigators will determine fecal excretion, synthesis, bile acid pool composition, and postprandial plasma response (Protocol B). These variables will be measured prior to surgery and one month after the procedure and also to the group of patients under medical treatment after a 10-kg diet-induced weight loss.
The expression of diverse enzymes, nuclear receptors, transcription factors, transporters as well as cell surface receptors will be quantified at messenger ribonucleic acid (mRNA) and protein level in liver biopsy samples obtained from patients at the time of gastric bypass or sleeve gastrectomy (Protocol C). Those parameters will be reevaluated in liver samples obtained from the same subjects within the first 12 months of the postoperative follow-up.
- Conditions
- Morbid Obesity
- Medical subject headings
- Obesity, Morbid
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of hormones and bile acids in patients that have undergone bariatric surgery
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startFeb 2013
- Primary completionMar 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica
- Responsible party
- Sponsor
- Investigators
- Alex G. Escalona, MD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366624
- Sponsor's protocol ID
- 11-126
- Status last verified
- Jun 2015
- First submitted
- 12 Feb 2015
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gastric Bypass, Sleeve Gastrectomy and Duodenal-jejunal Bypass on Bile Acid Homeostasis
- ClinicalTrials.gov ID
- NCT02366624
- Acronym / sponsor ID
- 11-126
- Conditions
- Morbid Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica
- Study start
- Feb 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Feb 2015 (estimated)
- 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.
The purpose of this study is to evaluate the effect of bariatric surgery in bile acid homeostasis and its interrelationship with the metabolic changes induced by the surgery.
This study contemplates the following hypothesis:
- Bariatric Surgery induce a new study state in bile acid homeostasis with higher bile acid synthesis in association with increased bile acid content.
- The major effects of bariatric surgery on bile acid synthesis and is observed one month after surgery with a progressively decline during the first year of follow-up.
- Gastric bypass increases serum bile acid content, postprandial plasma bile acid response and fecal bile acid excretion.
- Serum bile acids changes induced by gastric bypass are positively correlated with changes in gastric inhibitory polypeptide (GIP) levels and postprandial concentration of insulin and glucagon like peptide-1 (GLP-1) and inversely correlated with thyrotropic hormone (TSH) and postprandial concentration of glucose.
- Changes in postprandial plasma bile acid response induced by gastric bypass positively correlates with changes in postprandial concentration of insulin, GLP-1 and peptide YY (PYY) and inversely correlates postprandial response of ghrelin and glucose.
Detailed description
The proposed study will be conducted in adult subjects that will undergo to gastric bypass,sleeve gastrectomy or endoscopic duodenal-jejunal bypass.
as treatment for their obesity. As a first approach (Protocol A) in each of these groups the investigators will determine 7α-hydroxy-4-cholestene -3-one (C4) levels, a marker of bile acid synthesis, and fibroblast growth factor 19 (FGF19), inhibitor of the expression of Cholesterol 7- hydroxylase (CYP7A1), prior to surgery and then at months 1, 3, 6 and 12 of postoperative follow-up. The same measurements will be performed to a group of patients under medical treatment when they achieve 10-kg diet-induced weight loss, which is equivalent to one-month of surgically induced weight loss. Preliminary studies suggest that gastric bypass induces a greater weight loss and improvement of associated disease compared with sleeve gastrectomy and endoscopic duodenal-jejunal bypass. Therefore, we expect a deeper change in bile acid homeostasis after gastric bypass, than after the other procedures. For this reason, in patients with gastric bypass the investigators will determine fecal excretion, synthesis, bile acid pool composition, and postprandial plasma response (Protocol B). These variables will be measured prior to surgery and one month after the procedure and also to the group of patients under medical treatment after a 10-kg diet-induced weight loss.
The expression of diverse enzymes, nuclear receptors, transcription factors, transporters as well as cell surface receptors will be quantified at messenger ribonucleic acid (mRNA) and protein level in liver biopsy samples obtained from patients at the time of gastric bypass or sleeve gastrectomy (Protocol C). Those parameters will be reevaluated in liver samples obtained from the same subjects within the first 12 months of the postoperative follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Obese patients that have undergone bariatric surgery or medical treatment to lose weight.
Key inclusion criteria (4 listed)
- Male and Female, 18 to 50 years old.
- Body mass index(BMI)≥35 and <40 with comorbidities or BMI ≥40 and <45 with or without comorbidities.
- HbA1c<8%.
- Subjects willing to comply with study requirements.
Key exclusion criteria (6 listed)
- Previous cholecystectomy or gallbladder stones at baseline visit.
- Previous bariatric surgery, small bowel or colon resection.
- Use of drugs:cholestyramine,colesevelam,colestilan, colestimide, colestipol,insulin,exenatide, thiazolidinedione or dipeptidyl peptidase IV(DPPIV)inhibitors, selective serotonin re uptake inhibitor antidepressants.
- Pregnancy or intent to become pregnant.
- Cardiac, renal or liver failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analysis of hormones and bile acids in patients that have undergone bariatric surgery
Time frame: One year
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 26 Jun 2015.
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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.
Alex G. Escalona, MD principal investigator
Pontificia Universidad Catolica de Chile
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 Morbid Obesity, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 26 Jun 2015. 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 Chile. 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?
Analysis of hormones and bile acids in patients that have undergone bariatric surgery (time frame: One year). 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 26 Jun 2015.