Severe ObesityNCT01252511
Determinants of Fat Malabsorption After Roux-en-Y Gastric Bypass
A study testing RYGB for surgical treatment of severe obesity in people with Severe Obesity, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Obesity
- What is being tested?
- RYGB for surgical treatment of severe obesity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to 14 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with severe obesity (BMI equal to or greater than 50) who have been scheduled to receive Roux-en-Y gastric bypass.
Who cannot join
- Previous abdominal surgery, chronic diarrhea, and severe constipation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
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.
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.
Read the 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.
- Conditions
- Severe Obesity
- Being tested
- RYGB for surgical treatment of severe obesity
- Keywords
- Malabsorption after RYGB, Fat Malabsorption and maldigestion, Obesity surgery, Bariatric surgery
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RYGB for surgical treatment of severe obesityProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| long biliopancreatic limb, 75 cm | Active comparator | Not described Receives: Procedure: RYGB for surgical treatment of severe obesity |
| long Roux limb, 150 cm | Active comparator | Not described Receives: Procedure: RYGB for surgical treatment of severe obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selective fat malabsorption
To learn how to create an operation resulting in the predominance of fat malabsorption over protein malabsorption.
Measured: 1 year after RYGB surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionAug 2014
- Study completion14 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe ObesityStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John S Fordtran, MD, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252511
- Sponsor's protocol ID
- 010-271
- Status last verified
- Jan 2016
- First submitted
- 1 Dec 2010
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01252511
- Acronym / sponsor ID
- 010-271
- Conditions
- Severe Obesity
- Keywords
- Malabsorption after RYGB, Fat Malabsorption and maldigestion, Obesity surgery, Bariatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- 14 Jan 2017 (actual)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| long biliopancreatic limb, 75 cm | Active comparator | Procedure: RYGB for surgical treatment of severe obesity |
| long Roux limb, 150 cm | Active comparator | Procedure: RYGB for surgical treatment of severe obesity |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with severe obesity (BMI equal to or greater than 50) who have been scheduled to receive Roux-en-Y gastric bypass.
Key exclusion criteria (1 listed)
- Previous abdominal surgery, chronic diarrhea, and severe constipation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RYGB for surgical treatment of severe obesityTwenty 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. | Procedure or surgery | long Roux limb, 150 cm, long biliopancreatic limb, 75 cm |
Primary outcome
Selective fat malabsorption
Time frame: 1 year after RYGB surgery
To learn how to create an operation resulting in the predominance of fat malabsorption over protein malabsorption.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John S Fordtran, MD principal investigator
Baylor Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RYGB for surgical treatment of severe obesity in people with Severe Obesity, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Selective fat malabsorption (time frame: 1 year after RYGB surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2019.