Magnetic Resonance Imaging (MRI) Fat Quantification of the Liver
Primary Purpose
Non-alcoholic Fatty Liver Disease, Obesity
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
MR Abdomen
Sponsored by
About this trial
This is an interventional basic science trial for Non-alcoholic Fatty Liver Disease
Eligibility Criteria
Inclusion Criteria:
- morbidly obese patients with BMI over 35, scheduled for bariatric surgery (either sleeve gastrectomy or gastric bypass)
Exclusion Criteria:
- Smoking
- substance abuse
- Diabetes
- history of gastrointestinal disorders
- pace-maker
- claustrophobia
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Laparoscopic gastric bypass
Laparoscopic sleeve gastrectomy
Arm Description
MR Abdomen in morbidly obese patients receiving gastric bypass
MR Abdomen morbidly obese patients receiving sleeve gastrectomy
Outcomes
Primary Outcome Measures
Liver fat quantification
change in fat quantification; measurement of fat rate in the organ
Secondary Outcome Measures
Visceral fat quantification
change in fat quantification visceral; 2-point Dixon technique for volumetric fat imaging
Subcutaneous fat quantification
change in fat quantification subcutaneous; 2-point Dixon technique for volumetric fat imaging
Full Information
NCT ID
NCT02682173
First Posted
February 1, 2016
Last Updated
July 25, 2017
Sponsor
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT02682173
Brief Title
Magnetic Resonance Imaging (MRI) Fat Quantification of the Liver
Official Title
MRI Fat Quantification of the Liver, Subcutaneous and Visceral Fatty Tissue in Patients Before and After Bariatric Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Fatty liver in the obese is a common finding; some cases develop steato-hepatosis which in the long-term can lead to liver cirrhosis. The effect of bariatric surgery on fat distribution in the liver has so far been studied with liver biopsies and single voxel MR techniques. With this trial investigators present a new, whole organ MR-quantification of liver fat and describe changes after bariatric surgery in visceral and subcutaneous fat.
Detailed Description
Currently, liver biopsy is still regarded as the gold-standard in the diagnosis of non-alcoholic fatty liver disease and monitoring of progression. However, accuracy of diagnosis is not perfect with a certain risk of sampling error depending on biopsy quality and a more or less homogeneous distribution of liver tissue alterations. Complications are rare; however, the method is invasive and carries the risk of bleeding. Therefore, non-invasive methods (such as serum biomarkers or imaging techniques) are sought for accurate diagnosis and safe monitoring of disease progression. Unidimensional transient elastography (TE; FibroScan®) is a non-invasive technique, which can be a helpful tool here: however, accuracy of diagnosis is depending on the stage of fibrosis and lower grades of fibrosis (stage 1 and 2) are difficult to assess. Moreover, in obese patients this method cannot be applied.
In recent years, the development of fat-water magnetic resonance imaging has enabled non-invasive assessment of fat and water content in tissues. In addition, modern MRI devices allow brief breath holding, which reduces motion artifacts and provides us with excellent data and therefore MRI has become an important tool for fat quantification.
Up to date only a few studies have focused on fat quantification before and after bariatric surgery: patients treated with laparoscopic gastric banding (a purely restrictive procedure) and patients undergoing metabolic surgery such as sleeve gastrectomy and gastric bypass have been examined pre- and postoperatively by means of MRI fat quantification. However, in these studies single voxel spectroscopy was used. In contrast, in this current trial investigators aim to assess full organ volume, which hopefully will provide more accurate data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease, Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic gastric bypass
Arm Type
Active Comparator
Arm Description
MR Abdomen in morbidly obese patients receiving gastric bypass
Arm Title
Laparoscopic sleeve gastrectomy
Arm Type
Active Comparator
Arm Description
MR Abdomen morbidly obese patients receiving sleeve gastrectomy
Intervention Type
Other
Intervention Name(s)
MR Abdomen
Primary Outcome Measure Information:
Title
Liver fat quantification
Description
change in fat quantification; measurement of fat rate in the organ
Time Frame
within 3, 6 and 12 months of surgery
Secondary Outcome Measure Information:
Title
Visceral fat quantification
Description
change in fat quantification visceral; 2-point Dixon technique for volumetric fat imaging
Time Frame
within 3, 6 and 12 months of surgery
Title
Subcutaneous fat quantification
Description
change in fat quantification subcutaneous; 2-point Dixon technique for volumetric fat imaging
Time Frame
within 3, 6 and 12 months of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
morbidly obese patients with BMI over 35, scheduled for bariatric surgery (either sleeve gastrectomy or gastric bypass)
Exclusion Criteria:
Smoking
substance abuse
Diabetes
history of gastrointestinal disorders
pace-maker
claustrophobia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Beglinger, MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31089967
Citation
Meyer-Gerspach AC, Peterli R, Moor M, Madorin P, Schotzau A, Nabers D, Borgwardt S, Beglinger C, Bieri O, Wolnerhanssen BK. Quantification of Liver, Subcutaneous, and Visceral Adipose Tissues by MRI Before and After Bariatric Surgery. Obes Surg. 2019 Sep;29(9):2795-2805. doi: 10.1007/s11695-019-03897-2.
Results Reference
derived
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Magnetic Resonance Imaging (MRI) Fat Quantification of the Liver
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