Ursodeoxycholic Acid in Bariatric Surgery

Plain-language summary

This study examined the use of a drug called Ursodeoxycholic Acid (UDCA) in patients undergoing weight-loss (bariatric) surgery. It enrolled patients with a body mass index of 35 or above who were eligible for bariatric surgery. It was conducted as a trial with no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

Sahlgrenska University Hospital

Intervention

Ursodeoxycholic Acid (UDCA)

Start date

10/1/2008

Estimated completion

5/1/2010

Related genes

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.