Changes in bile acids and microbiota after bariatric surgery

Completed

• Conditions: Metabolism of bile acids, gastrointestinal hormones and gut microbiota following different bariatric surgery techniques; Surgery

• Registration Number: ISRCTN81954082
• Lead Sponsor: Fondo de Investigaciones Sanitarias - Instituto de Salud Carlos III-FEDER (PI-16/01655)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-24
• Last Update Posted: 19 March 2018
• Study Completion: 2020-02-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. Patients on the bariatric surgery waiting list
2. Caucasian men and women aged 18-65
3. BMI = 40 kg/m2 or = 35 kg/m2 with at least one major comorbidities (Type 2 diabetes, hypertension, hyperlipemia, sleep obstructive apnea)
4. Absence of serious disease (chronic kidney disease, liver disease, neurological disease)
5. Absence of psychiatric pathology
6. Ability to understand the mechanisms involved in the surgery that will be proposed
7. Written informed consent to participate in the study

Inclusion criteria for the control group:
1. Caucasian men and women, aged 18-65 years (matched with patients)
2. BMI 20-29.9 kg/m2
3. No pregnant and lactating women
4. Absence of major comorbidities (Type 2 diabetes, hypertension, hyperlipidemia, sleep obstructive apnea)
5. Absence of serious diseases (chronic kidney or liver disease, inflammatory diseases, neurological diseases, cancer, AIDS)
6. Absence of psychiatric disorders
7. Written informed consent to participate in the study

Exclusion Criteria

1. Systemic disease not associated with obesity (inflammatory bowel disease, inflammatory rheumatic disease)
2. Hepatitis C, known cirrhosis (or discovered during the study)
3. HIV
4. Drug and/or alcohol abuse
5. Eating disorders

Study & Design

• Study Type: Observational
• Study Design: Not specified