Ursodeoxycholic Acid in Bariatric Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanns-Ulrich Marschall, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01548079
First received: February 22, 2012
Last updated: December 2, 2013
Last verified: December 2013

February 22, 2012
December 2, 2013
October 2008
November 2009   (final data collection date for primary outcome measure)
Changes in regulators of lipid turnover [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
Trial objectives are to determine whether (i) Hepatic and/or visceral white adipose tissue (WAT) lipase activity determines fatty acid (FA) release/balance from lipid triglyceride (TG) droplets and FA-mediated lipotoxicity in NAFLD; differences in hepatic and/or WAT activity could explain individual susceptibility to pure NAFL versus NASH (ii) UDCA (20 mg/kg/day) improves insulin resistance in patients with NAFLD (iii) UDCA improves hepatobiliary transporter expression in NAFLD
Same as current
Complete list of historical versions of study NCT01548079 on ClinicalTrials.gov Archive Site
Changes in serum bile acids and lipids [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
  • relative changes in hepatic basolateral transport proteins MRP3, MRP4, OATP, SLC21A1
  • relative changes in m RNA expression levels of BAAT; CYP3A4, CYP7A1, CYP27, CYP8B1, UGT1A1, UGT2B4, UGT2B7, SULT2A1, HNF-4α, PXR/NR1I2, RXR/NR1B1; PERK, XBP-1, SREBP-1c; TNF-α, IL-6, IL-10, MCP-1, CxCl-1
  • relative change in serum bile acids
  • relative change in plasma 7α-hydroxy-4-cholesten-3-one and FGF-19
  • relative changes in total cholesterol, LDL-C, HDL-C, Apo A1, Apo B, in Lp(A)
Same as current
Not Provided
Not Provided
 
Ursodeoxycholic Acid in Bariatric Surgery
Effects of Ursodeoxycholic Acid on Hepatobiliary Detoxification/Elimination Mechanisms and Hepatic Fatty Acid/Triglyceride Metabolism in Morbidly Obese Patients.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Non-alcoholic Fatty Liver Disease
  • Morbid Obesity
Drug: Ursodeoxycholic Acid (UDCA)
20mg/kg/day UDCA in three weeks
  • No Intervention: Control
    Untreated controls
  • Active Comparator: Ursodeoxycholic acid
    Oral ursodeoxycholic acid 20 mg/kg/day in three weeks
    Intervention: Drug: Ursodeoxycholic Acid (UDCA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2010
November 2009   (final data collection date for primary outcome measure)

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.
Both
25 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01548079
UDCAINBS
No
Hanns-Ulrich Marschall, Sahlgrenska University Hospital, Sweden
Sahlgrenska University Hospital, Sweden
Not Provided
Principal Investigator: Hanns-Ulrich Marschall, MD, PhD Sahlgrenska Academy and University Hospital, Institute of Medicine, Dept. of Internal Medicine, University of Gothenburg, S-41345 Gothenburg
Sahlgrenska University Hospital, Sweden
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP