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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT01252511
First received: December 1, 2010
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Severe Obesity
Procedure: RYGB for surgical treatment of severe obesity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • Selective fat malabsorption [ Time Frame: 1 year after RYGB surgery ] [ Designated as safety issue: Yes ]
    To learn how to create an operation resulting in the predominance of fat malabsorption over protein malabsorption.


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: long biliopancreatic limb, 75 cm Procedure: RYGB for surgical treatment of severe obesity
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.
Active Comparator: long Roux limb, 150 cm Procedure: RYGB for surgical treatment of severe obesity
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252511

Locations
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
Investigators
Principal Investigator: John S Fordtran, MD Baylor Health Care System
  More Information

No publications provided

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01252511     History of Changes
Other Study ID Numbers: 010-271
Study First Received: December 1, 2010
Last Updated: August 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor Research Institute:
Malabsorption after RYGB
Fat Malabsorption and maldigestion
Obesity surgery
Bariatric surgery

Additional relevant MeSH terms:
Malabsorption Syndromes
Obesity
Obesity, Morbid
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 21, 2014