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Effect of Bariatric Surgery on Bile Acid Homeostasis

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ClinicalTrials.gov Identifier: NCT02366624
Recruitment Status : Completed
First Posted : February 19, 2015
Last Update Posted : June 26, 2015
Sponsor:
Collaborator:
Comisión Nacional de Investigación Científica y Tecnológica
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Brief 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 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.

Condition or disease
Morbid Obesity

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 104 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Effect of Gastric Bypass, Sleeve Gastrectomy and Duodenal-jejunal Bypass on Bile Acid Homeostasis
Study Start Date : February 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Analysis of hormones and bile acids in patients that have undergone bariatric surgery [ Time Frame: One year ]

Biospecimen Retention:   Samples Without DNA
  • Blood samples (serum and plasma).
  • Stool samples.
  • Liver samples.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Obese patients that have undergone bariatric surgery or medical treatment to lose weight.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02366624


Locations
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Chile
Pontificia Universidad Catolica de Chile
Santiago, Region Metropolitana, Chile
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Comisión Nacional de Investigación Científica y Tecnológica
Investigators
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Principal Investigator: Alex G. Escalona, MD Pontificia Universidad Catolica de Chile

Additional Information:

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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT02366624     History of Changes
Other Study ID Numbers: 11-126
First Posted: February 19, 2015    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Bile Acids and Salts
Gastrointestinal Agents