- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02366624
Effect of Bariatric Surgery on Bile Acid Homeostasis
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Region Metropolitana
-
Santiago, Region Metropolitana, Chile
- Pontificia Universidad Catolica de Chile
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Analysis of hormones and bile acids in patients that have undergone bariatric surgery
Time Frame: One year
|
One year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alex G. Escalona, MD, Pontificia Universidad Catolica de Chile
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-126
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Morbid Obesity
-
ClinTrio Ltd.UnknownMorbid Obesity Requiring Bariatric SurgeryBelgium, Germany, Portugal, Austria, Netherlands, Poland, Saudi Arabia
-
Centre Hospitalier Universitaire de NiceCompletedMorbid Obesity D009765France
-
Shanghai Jiao Tong University School of MedicineUnknown
-
Hospices Civils de LyonCentre de Recherche en Nutrition Humaine Rhone-Alpe; Institut National de Recherche... and other collaboratorsRecruiting
-
Endolumik, IncWest Virginia UniversityNot yet recruitingMorbid ObesityUnited States
-
Rijnstate HospitalRecruiting
-
Laval UniversityCentre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie...Recruiting
-
University of WashingtonUnited States Department of DefenseWithdrawn
-
Helsinki University Central HospitalActive, not recruiting
-
IHU StrasbourgWithdrawnMorbid Obesity