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Changes in bile acids and microbiota after bariatric surgery

Role of gastrointestinal hormones and bile acids on microbiota in bariatric surgery with different degrees of malabsorption

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN81954082
Enrollment
96
Registered
2018-02-24
Start date
2018-03-01
Completion date
Unknown
Last updated
2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

This study will include bariatric surgery candidates with different degrees of intestinal malabsorption (gastric bypass or biliopancreatic derivation), according to the clinical pathway protocol used

Sponsors

Fondo de Investigaciones Sanitarias - Instituto de Salud Carlos III-FEDER (PI-16/01655)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. Bile acids, measured at baseline and 1 year after bariatric surgery 2. Gastrointestinal hormones (FGF19, incretins GLP1 and PYY incretins), measured at baseline and 1 year after bariatric surgery 3. Gut microbiota profile, measured at baseline and 1 year after bariatric surgery

Secondary

MeasureTime frame
1. The synthesis capability of bile acids by hepatocytes studied through the serum C4 (7a-hydroxy-4-cholesten-3-one), used as an enzymatic marker of cholesterol-7a-hydroxylase, measured at baseline and 1 year after bariatric surgery 2. Malabsorption of bile acids, determined by the isotopic test SeHCAT at 1 year after bariatric surgery 3. Potential biomarkers of liver damage associated with fatty liver (cytokeratin-18 (CK-18) and its fractions M30/M65 and alpha-ketoglutarate), measured at 1 year after bariatric surgery

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026