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Ursodeoxycholic Acid in Bariatric Surgery

NCT ID: NCT01548079

Last Updated: 2013-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-05-31

Brief Summary

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In an open-label trial, 20 otherwise healthy morbidly obese patients scheduled for bariatric surgery will be administered 20 mg/kg/day ursodeoxycholic acid for three weeks until the day before surgery. The maximum dose will be 3 g/day. Twenty other patients will serve as controls. Serum from days 1 and 21 will be analyzed for routine liver tests, bile acids, a complete lipid profile including FA and in addition for 7α-hydroxy-4-cholesten-3-one and fibroblast growth factor 19 (FGF-19), markers for bile acid synthesis its intestinal stimulation. For the evaluation of insulin resistance and possible pre-diabetes, plasma will be taken for the estimation of homeostasis model assessment (HOMA) index and oral glucose tolerance test (OGTT) will be performed at days 1 and 21. At surgery, a liver biopsy (0.5-1 g) and a white adipose tissue (WAT) specimen (1 cm2) will be taken and immediately frozen in liquid nitrogen for messenger ribonucleic acid (mRNA) and protein preparation for quantitative real-time polymerase chain reaction (RT-PCR) and Western analysis, respectively, histopathological Non-alcoholic fatty liver disease (NAFLD) grading, and measuring of hepatic and white adipose tissue (WAT) lipase activity. In all patients at randomization, abdominal ultrasound will be performed for the detection of NAFLD and gallstones and a blood sample will be taken for the analysis of polymorphisms of hepatic lipid synthesis, storage, fatty acid (FA) oxidation and export genes. Six month after operation, HOMA, OGTT and abdominal ultrasound will be repeated.

Detailed Description

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Conditions

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Non-alcoholic Fatty Liver Disease Morbid Obesity

Keywords

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ursodeoxycholic acid fatty liver disease morbid obesity bariatric surgery NAFLD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Control

Untreated controls

Group Type NO_INTERVENTION

No interventions assigned to this group

Ursodeoxycholic acid

Oral ursodeoxycholic acid 20 mg/kg/day in three weeks

Group Type ACTIVE_COMPARATOR

Ursodeoxycholic Acid (UDCA)

Intervention Type DRUG

20mg/kg/day UDCA in three weeks

Interventions

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Ursodeoxycholic Acid (UDCA)

20mg/kg/day UDCA in three weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI ≥ 35 kg/m2
* Patients eligible to bariatric surgery
* Patients should have given their written consent to participate in this study

Exclusion Criteria

* Chronic liver disease other than NAFLD (viral hepatitis, autoimmune liver disease, hemochromatosis, homozygous alpha1-antitrypsin deficiency and Wilson disease)
* Partial ileal bypass
* Inflammatory bowel disease
* Uncontrolled diabetes mellitus (fasting blood glucose \> 6.7 mmol/L), hypothyroidism or hyperthyroidism, or other significant endocrine disease.
* A subject who is euthyroid on a stable replacement dose of thyroid hormone is acceptable provided the TSH is within normal range.
* Other serious disease
* Known hypersensitivity to ursodeoxycholic acid
* Patients who will not comply with the protocol.
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hanns-Ulrich Marschall

Professor, senior consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hanns-Ulrich Marschall, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska Academy and University Hospital, Institute of Medicine, Dept. of Internal Medicine, University of Gothenburg, S-41345 Gothenburg

References

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Mueller M, Castro RE, Thorell A, Marschall HU, Auer N, Herac M, Rodrigues CMP, Trauner M. Ursodeoxycholic acid: Effects on hepatic unfolded protein response, apoptosis and oxidative stress in morbidly obese patients. Liver Int. 2018 Mar;38(3):523-531. doi: 10.1111/liv.13562. Epub 2017 Sep 18.

Reference Type DERIVED
PMID: 28853202 (View on PubMed)

Other Identifiers

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UDCAINBS

Identifier Type: -

Identifier Source: org_study_id