Ursodeoxycholic Acid in Bariatric Surgery
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ClinicalTrials.gov Identifier: NCT01548079 |
Recruitment Status
:
Completed
First Posted
: March 8, 2012
Last Update Posted
: December 3, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-alcoholic Fatty Liver Disease Morbid Obesity | Drug: Ursodeoxycholic Acid (UDCA) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Effects of Ursodeoxycholic Acid on Hepatobiliary Detoxification/Elimination Mechanisms and Hepatic Fatty Acid/Triglyceride Metabolism in Morbidly Obese Patients. |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | November 2009 |
Actual Study Completion Date : | May 2010 |

Arm | Intervention/treatment |
---|---|
No Intervention: Control
Untreated controls
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Active Comparator: Ursodeoxycholic acid
Oral ursodeoxycholic acid 20 mg/kg/day in three weeks
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Drug: Ursodeoxycholic Acid (UDCA)
20mg/kg/day UDCA in three weeks
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- Changes in regulators of lipid turnover [ Time Frame: Baseline and 3 weeks ]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
- Changes in serum bile acids and lipids [ Time Frame: Baseline and 3 weeks ]
- 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)

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Ages Eligible for Study: | 25 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548079
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 |
Responsible Party: | Hanns-Ulrich Marschall, Professor, senior consultant, Sahlgrenska University Hospital, Sweden |
ClinicalTrials.gov Identifier: | NCT01548079 History of Changes |
Other Study ID Numbers: |
UDCAINBS |
First Posted: | March 8, 2012 Key Record Dates |
Last Update Posted: | December 3, 2013 |
Last Verified: | December 2013 |
Keywords provided by Hanns-Ulrich Marschall, Sahlgrenska University Hospital, Sweden:
ursodeoxycholic acid fatty liver disease morbid obesity bariatric surgery NAFLD |
Additional relevant MeSH terms:
Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Obesity, Morbid Digestive System Diseases Obesity Overnutrition |
Nutrition Disorders Overweight Body Weight Signs and Symptoms Ursodeoxycholic Acid Cholagogues and Choleretics Gastrointestinal Agents |