Clinical trial NCT00701376: Hepatic Effects of Gastric Bypass Surgery
Official title: Long Term Hepatic Effects of Gastric Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Diseases
Keywords: Gastric Bypass surgery
Hepatic disease
Hepatic function
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-06-19
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Liver disease in the morbidly obese is thought to occur due to the long-term presence of fat deposits in the liver, resulting in inflammation and scarring of the liver over time, which reduces liver function. However, many of these patients are unaware that their liver is damaged. There is currently no consensus regarding what the long-term effects of gastric bypass surgery are on pre-existing liver disease in morbidly obese patients. This study will determine the long-term effects on the liver after this type of surgical procedure.

Detailed description: Before or on the day of surgery liver function will be determined using the DDG-2001 Analyzer. This monitor is able to detect the concentration of a dye called indocyanine green dye (ICG) when present in the blood stream. A dose of 0.5 mg/kg of ICG will be injected into an IV in the arm. Over approximately fifteen minutes the DDG-2001 Analyzer will determine how quickly the liver removes the dye ICG from the blood stream. This value represents how well the liver is functioning. Blood samples are drawn before injection of ICG to measure liver function using standard liver function tests.

This same routine for injecting ICG and obtaining blood for routine liver function tests will happen one more time, after surgery, once the subject has lost a significant amount of the original weight (60% of excess weight). This amount of weight loss typically occurs between 12 to 18 months after gastric bypass surgery. This second ICG measurement will occur during an outpatient follow-up visit to CCF.

A biopsy will be taken from the liver during surgery. A second biopsy taken after the 60% weight loss will be compared to determine the effect of this surgery on the liver.

Eligibility criteria: Inclusion Criteria:

1. BMI \> 40.
2. Documented failed non-surgical treatment for morbid obesity.
3. Ability to undergo long-term follow-up after LGBS.

Exclusion Criteria:

1. BMI \< 40.
2. Subject age \< 18 years.
3. Inability to undergo long-term follow-up after LGBS (living distance \> 300 miles).
4. Patients with known ESLD.
5. Patients found to have evidence of ESLD during preoperative evaluation for LGBS including portal hypertension, ascites, and coagulopathy.
6. Patients with known iodine sensitivity or allergy.

Primary outcomes:
measure: Aspartate Transaminase (AST) Change
timeFrame: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
measure: Alanine Transaminase (ALT) Change
timeFrame: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
measure: Alkaline Phosphate (ALK)
timeFrame: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
measure: Total Bilirubin
timeFrame: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
measure: Albumin
timeFrame: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
measure: Prothrombin Time (PT)
timeFrame: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
measure: Partial Thromboplastin Time (PTT)
timeFrame: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
measure: Indocyanine Green (ICG) K Value
timeFrame: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
measure: Number of Subjects of Nonalcoholic Steatohepatitis (NAS Steatosis)
timeFrame: when patients lost 60% of their preoperative excess weight or weight loss had plateaued.
measure: Number of Subjects of Nonalcoholic Steatohepatitis Lobular Inflammation
timeFrame: when patients lost 60% of their preoperative excess weight or weight loss had plateaued.
measure: Fibrosis
timeFrame: after surgery once they lost 60% of their preoperative excess weight or weight loss had plateaued
measure: Nonalcoholic Steatohepatitis (NAS) Hepatocyte Balloon
timeFrame: once patients lost 60% of their preoperative excess weight or weight loss had plateaued after surgery
Secondary outcomes:
measure: Diagnostic Accuracy-AST
timeFrame: before RYGB surgery
measure: Diagnostic Accuracy-ALT
timeFrame: before RYGB surgery
measure: Diagnostic Accuracy-ALK
timeFrame: before RYGB surgery
measure: Diagnostic Accuracy-total Bilirubin
timeFrame: before RYGB surgery
measure: Diagnostic Accuracy-PT
timeFrame: before RYGB surgery
measure: Diagnostic Accuracy-PTT
timeFrame: before RYGB surgery
measure: Diagnostic Accuracy-ICG k Value
timeFrame: before RYGB surgery
measure: Diagnostic Accuracy-albumin
timeFrame: before RYGB surgery
measure: Diagnostic Accuracy-multiple Factor
timeFrame: before RYGB surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Brian M. Parker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: STUDY_CHAIR
References: