NCT02682173

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

4.3 years

First QC Date

February 1, 2016

Last Update Submit

July 25, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Liver fat quantification

    change in fat quantification; measurement of fat rate in the organ

    within 3, 6 and 12 months of surgery

Secondary Outcomes (2)

  • Visceral fat quantification

    within 3, 6 and 12 months of surgery

  • Subcutaneous fat quantification

    within 3, 6 and 12 months of surgery

Study Arms (2)

Laparoscopic gastric bypass

ACTIVE COMPARATOR

MR Abdomen in morbidly obese patients receiving gastric bypass

Other: MR Abdomen

Laparoscopic sleeve gastrectomy

ACTIVE COMPARATOR

MR Abdomen morbidly obese patients receiving sleeve gastrectomy

Other: MR Abdomen

Interventions

Laparoscopic gastric bypassLaparoscopic sleeve gastrectomy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • morbidly obese patients with BMI over 35, scheduled for bariatric surgery (either sleeve gastrectomy or gastric bypass)

You may not qualify if:

  • Smoking
  • substance abuse
  • Diabetes
  • history of gastrointestinal disorders
  • pace-maker
  • claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Basel, CH-4031, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseObesity

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christoph Beglinger, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 15, 2016

Study Start

March 1, 2013

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 27, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations