Metabolic Syndrome, Bile Acids, Hepatocellular Carcinoma and Cholangiocarcinoma

NCT02730611 | Completed

• 1 other identifier: PRT-K14-038
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Increasing rates of highly malignant hepatocellular carcinoma (HCC) and biliary tract cancers (GBTC) observed in Western populations may be related to obesogenic lifestyle factors and their metabolic consequences, such as metabolic syndrome (MetS), inflammation and altered production of bile acids (BA). Such lifestyle behaviours may induce changes in the gut microflora which in turn affect BA profiles, increasing their carcinogenicity. Some elevated BA may be oncogenic in exposed liver, bile ducts and gall bladder. Vertical sleeve gastrectomy may change bile acid composition. The aims of this study are:

1. 1.whether specific presurgical bila acid profiles are predictive of efficacy of vertical sleeve gastrectomy, reflective of liver function and metabolic dysfunction;
2. 2.whether specific presurgical bile acid profiles are predictive of the efficacy of sleeve gastrectomy

Conditions

Morbid Obesity; Vertical Sleeve Gastrectomy; Metabolic Syndrome; Hepatocellular Carcinoma; Cholangiocarcinoma; Disorder of Bile Acid and Cholesterol Metabolism

Keywords

Vertical sleeve gastrectomy; Metabolic syndrome; Disorder of Bile Acid and Cholesterol Metabolism; Cholangiocarcinoma; Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Blood bile acids (micromols per liter)

  at one year after surgery

Secondary Outcomes (1)

• Hepatic FXR expression

  At baseline

Study Arms (1)

Patients

Patients with morbid obesity and vertical sleeve gastrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who undergo vertical sleeve gastrectomy

You may qualify if:

• Patients who undergo vertical sleeve gastrectomy

You may not qualify if:

• No liver histology

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• National Cancer Institute, France: collaborator
• Centre International de la Recherche sur le Cancer: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

AP-HP, Antoine Béclère Hospital

Clamart, 92141, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Feces, blood, liver biopsy

MeSH Terms

Conditions

Obesity, Morbid; Metabolic Syndrome; Carcinoma, Hepatocellular; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Gabriel PERLEMUTER, MD, PhDi

  Assistance Publique - Hôpitaux de Paris, Antoine Béclère Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: April 6, 2016
• Study Start: March 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2018
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)