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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 3 August 2015
Main ID:  NCT02366624
Date of registration: 12/02/2015
Prospective Registration: No
Primary sponsor: Pontificia Universidad Catolica de Chile
Public title: Effect of Bariatric Surgery on Bile Acid Homeostasis
Scientific title: Effect of Gastric Bypass, Sleeve Gastrectomy and Duodenal-jejunal Bypass on Bile Acid Homeostasis
Date of first enrolment: February 2013
Target sample size: 104
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02366624
Study type:  Observational [Patient Registry]
Study design:  Observational Model: Case Control, Time Perspective: Prospective  
Phase: 
Countries of recruitment
Chile
Contacts
Name:     Alex G. Escalona, MD
Address: 
Telephone:
Email:
Affiliation:  Pontificia Universidad Catolica de Chile
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Morbid Obesity
Intervention(s)
Primary Outcome(s)
Analysis of hormones and bile acids in patients that have undergone bariatric surgery [Time Frame: One year]
Secondary Outcome(s)
Secondary ID(s)
11-126
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Comisión Nacional de Investigación Científica y Tecnológica
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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