Changes in bile acids and microbiota after bariatric surgery
| ISRCTN | ISRCTN81954082 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81954082 |
| Protocol serial number | FIS PI-16/01655 |
| Sponsor | Fondo de Investigaciones Sanitarias - Instituto de Salud Carlos III-FEDER (PI-16/01655) |
| Funder | Instituto de Salud Carlos III |
- Submission date
- 06/02/2018
- Registration date
- 24/02/2018
- Last edited
- 22/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Bariatric (weight loss) surgery has proved to be an effective treatment for patients with morbid obesity, but results vary according to the specific type of technique performed. The aim of this study is to find out whether two different techniques (gastric bypass and biliopancreatic diversion) result in different outcomes regarding body weight and associated illnesses (diabetes, dyslipidemia, liver steatosis). Gastric bypass involves making the stomach smaller and bypassing part of the intestines (bowels), so that fewer calories are absorbed. A biliopancreatic diversion is similar, except the stomach is connected further along the small intestine.
Who can participate?
Patients aged 18-65 with morbid obesity on the bariatric surgery waiting list, and non-obese healthy volunteers for comparison
What does the study involve?
Changes in gastrointestinal (digestive system) hormones, biliary acids and gut microbiota (bacteria are studied by collecting blood and stool samples before and one year after bariatric surgery. A liver biopsy (sample) is also taken during surgery.
What are the possible benefits and risks of participating?
Participants will find out about their specific hormone response and changes in gut microbiota, which may allow them to change, for instance, their diet to obtain better outcomes. These tests are simple and do not involve any further risk, and will help to show which bariatric technique is better for patients with obesity and associated illnesses.
Where is the study run from?
Hospital Clínico San Carlos (Spain)
When is the study starting and how long is it expected to run for?
August 2017 to February 2020
Who is funding the study?
Institute of Health Carlos III (Spain)
Who is the main contact?
Dr Miguel A. Rubio
Contact information
Scientific
Endocrinology and Nutrition Department.
Hospital Clínico San Carlos. C/Professor Martín Lagos s/n
Madrid
28040
Spain
 ORCID ID |
0000-0002-0495-6240 |
|---|
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre case-control prospective observational study |
| Secondary study design | Longitudinal study |
| Study type | Participant information sheet |
| Scientific title | Role of gastrointestinal hormones and bile acids on microbiota in bariatric surgery with different degrees of malabsorption |
| Study objectives | Bariatric surgery techniques with different degrees of intestinal malabsorption can modify the metabolism of bile acids (synthesis, absorption and intestinal conjugation/deconjugation), entailing impacts on self-regulation mechanisms and gut microbiota. |
| Ethics approval(s) | Comité Ético de Investigación Clínica del Hospital Clínico San Carlos (San Carlos Hospital Ethics Committee), 22/11/2016, ref: 16/229-E_BC |
| Health condition(s) or problem(s) studied | Metabolism of bile acids, gastrointestinal hormones and gut microbiota following different bariatric surgery techniques |
| Intervention | 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 at our hospital. The trialists will study bile acids and gastrointestinal hormones after a meal test, and microbiota samples, at 2 stages of follow-up: pre-surgery (T1), and 12 months after surgery (T2). They will also collect information from a non-obese sample (control group), comparable in age and gender, for dynamic gastrointestinal and bile acid secretion (meal test), and microbiota studies. They will analyze fasting and postprandial bile acid levels, the bile acid activation of FXR receptors (FGF19 signaling) and TGR5 receptors (mediated by PYY and GLP1 incretins) and its effect on the patients gut microbiota. The degree of bile acid malabsorption following surgery will be assessed by SeHCAT scanning. As a secondary objective, they will analyze the evolution of the patients with non-alcoholic steatosis (NALF) by liver biopsy during surgery, measuring the serum biomarkers of NALF cytokeratin-18 and α-ketoglutarate. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Bile acids, measured at baseline and 1 year after bariatric surgery |
| Key secondary outcome measure(s) |
1. The synthesis capability of bile acids by hepatocytes studied through the serum C4 (7α-hydroxy-4-cholesten-3-one), used as an enzymatic marker of cholesterol-7α-hydroxylase, measured at baseline and 1 year after bariatric surgery |
| Completion date | 28/02/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 96 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2018 |
| Date of final enrolment | 31/07/2018 |
Locations
Countries of recruitment
- Spain
Study participating centre
Madrid
28040
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Datasets will be available upon request from Dr Miguel A. Rubio. The data will be archived in a repository and become available when requested, for a period of 10 years. The type of data that will be provided are both the database (with anonymous data) and statistical analyses. Data will be provided once permission is granted, upon request. All the analyses performed will be available at the repository. Consent written forms will be obtained from all participants. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
