search
Back to results

Determinants of Fat Malabsorption After Roux-en-Y Gastric Bypass

Primary Purpose

Severe Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RYGB for surgical treatment of severe obesity
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Obesity focused on measuring Malabsorption after RYGB, Fat Malabsorption and maldigestion, Obesity surgery, Bariatric surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with severe obesity (BMI equal to or greater than 50) who have been scheduled to receive Roux-en-Y gastric bypass.

Exclusion Criteria:

  • Previous abdominal surgery, chronic diarrhea, and severe constipation.

Sites / Locations

  • Baylor University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

long biliopancreatic limb, 75 cm

long Roux limb, 150 cm

Arm Description

Outcomes

Primary Outcome Measures

Selective fat malabsorption
To learn how to create an operation resulting in the predominance of fat malabsorption over protein malabsorption.

Secondary Outcome Measures

Full Information

First Posted
December 1, 2010
Last Updated
May 15, 2019
Sponsor
Baylor Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT01252511
Brief Title
Determinants of Fat Malabsorption After Roux-en-Y Gastric Bypass
Official Title
Surgical Treatment of Severe Obesity by Roux-en-Y Gastric Bypass: a Randomized Prospective Study on the Effect of Reciprocal Changes in Y-limb Lengths on Intestinal Absorption of Dietary Fat, Protein and Carbohydrate.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
January 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether or not the length of the biliopancreatic limb of the Roux-en-Y anastamosis plays a critical role in the development of malabsorption after gastric bypass for treatment of severe obesity.
Detailed Description
Successful surgical treatment of severe obesity by RYGB is believed to require a procedure that (a) restricts the consumption of combustible food energy, and (b) reduces the intestinal absorption of food energy that is consumed. However, with RYGB operations that are currently employed, many patients do not develop the malabsorption they presumably require to produce good long term control of their body weight. It is important to find a way to do RYGB surgery in a way that consistently produces a moderate degree of fat malabsorption. Patients who are scheduled to receive a RYGB for treatment of severe obesity will be randomly assigned to receive 2 variations of the standard operation. The stomach and duodenal bypass, and the creation of a small gastric pouch will be exactly the same for all patients. There will be differences in the two jejunal limbs which create the Roux-en-Y anastomosis. In Procedure A, the Roux limb length will be 150 cm, and the biliopancreatic limb will contain 40 cm of jejunum. In Procedure B, the Roux limb length will be 110 cm and the biliopancreatic limb will contain 80 cm of jejunum. The total length of jejunum in both limbs is 190 cm in both procedures. Thus, the only difference between procedures A and B is that B procedure has a larger percentage of jejunum in the biliopancreatic limb (80/190=42%) than procedure A (40/190 = 21%). A total of 20 patients will be studied, 10 with each procedure. Before and after RYGB, the patients will be studied in a clinical research laboratory. Dietary intake and intestinal absorption of fat, protein, carbohydrate and combustible energy will be measured by metabolic balance techniques for 72 hours. We hypothesize that fat malabsorption after bypass will be greater and more consistent in patients who receive the longer biliopancreatic limb than in the patients who receive the longer Roux limb.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Obesity
Keywords
Malabsorption after RYGB, Fat Malabsorption and maldigestion, Obesity surgery, Bariatric surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
long biliopancreatic limb, 75 cm
Arm Type
Active Comparator
Arm Title
long Roux limb, 150 cm
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
RYGB for surgical treatment of severe obesity
Intervention Description
Twenty severely obese patients who have been scheduled to receive long limb RYGB will be enrolled in the study. By randomization, 10 patients will have a biliopancreatic limb that includes 40 cm of jejunum and a Roux limb that contains 150 cm of jejunum. The other 10 patients will receive a biliopancreatic limb that contains 75 cm of jejunum and a Roux limb of 115 cm.
Primary Outcome Measure Information:
Title
Selective fat malabsorption
Description
To learn how to create an operation resulting in the predominance of fat malabsorption over protein malabsorption.
Time Frame
1 year after RYGB surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with severe obesity (BMI equal to or greater than 50) who have been scheduled to receive Roux-en-Y gastric bypass. Exclusion Criteria: Previous abdominal surgery, chronic diarrhea, and severe constipation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John S Fordtran, MD
Organizational Affiliation
Baylor Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Determinants of Fat Malabsorption After Roux-en-Y Gastric Bypass

We'll reach out to this number within 24 hrs