ObesityNCT02302898
Roux-en-Y Gastric Bypass and Weight Regain
An observational study of Obesity, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study compares eating behaviors, meal size, and the size of the gastric pouch and connection between the gastric pouch and small intestine in patients who had gastric bypass surgery two or more years ago and regained weight compared with patients who had gastric bypass surgery two or more years ago and maintained… Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Eating Behavior Evaluation, Measurement of Functional gastric volume and Measurement of gastric pouch and GJ size
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Jun 2016
- Phase
- Observational
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population will consist of 20 patients who had laparoscopic RYGB surgery >2 years before screening and have regained >20% weight from their maximum weight lost after surgery and 20 patients who had laparoscopic RYGB surgery >2 years before screening and have maintained at least 90% weight loss from the maximum weight loss after surgery. These patients will be identified from the bariatric surgical population at Washington University School of Medicine.
Who may be able to join
- Ages of 21 and 60
- Laparoscopic RYGB surgery >2 years before screening
- Regained >20% weight from their maximum weight lost after surgery or maintained at least 90% weight loss from the maximum weight loss after surgery
Who cannot join
- Allergy to lidocaine, nut allergies, milk intolerance or any other food allergies/restrictions that are included in our test meals
- A history of alcohol abuse
- Currently consuming >20 gm of alcohol per day
- Greater than 2 points on the MAST
- Severe organ dysfunction
- Anemia (hemoglobin <10mg/dl)
Show all 15Show fewer
- PT, PTT and INR > 1.5x UNL
- Triglycerides > 400
- LFT > 2x UNL
- Women who are pregnant or lactating
- Participants that smoke greater than 20 pack years
- Actively using illegal drugs
- Depression or other psychological disorders that are untreated
- Diabetics receiving Insulin
- Patients that have been hospitalized and/or had surgery in the last three months that may be unstable (PI will determine this at Physical Exam)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Characteristics Associated With Weight Regain After Roux-en-Y Gastric Bypass
This study compares eating behaviors, meal size, and the size of the gastric pouch and connection between the gastric pouch and small intestine in patients who had gastric bypass surgery two or more years ago and regained weight compared with patients who had gastric bypass surgery two or more years ago and maintained their weight loss.
Read the detailed description
Obesity affects a third of adults in the United States. The most effective treatment for weight loss is bariatric surgery, and the most common surgery performed in the US is Roux-en-Y Gastric Bypass (RYGB). However, a significant number of patients regain weight that was lost after surgery. The mechanisms for weight regain are likely multifactorial, but not well understood. Disordered eating behaviors and dilated gastrojejunostomies (GJ), which presumably allows a patient to consume larger portion sizes during a meal, correlate with weight regain. Moreover, some data suggest that changes to the gut anatomy may drive eating behaviors and food preferences. However, no studies have simultaneously evaluated functional gastric volume (the volume of solid or liquid food that can be consumed to a level of comfortable fullness in one sitting), anatomical gastric pouch size and GJ diameter, and eating behaviors in patients who maintained their post RYGB weight compared with patients who have regained weight from their maximum weight loss after RYGB to determine the relationship among post RYGB eating behavior, functional and anatomical gastric pouch size, GJ diameter and weight change. Accordingly, the objectives of this proposal are to compare 1) eating behaviors 2) functional gastric volume and 3) anatomical dimensions of the gastric pouch and GJ in patients who are >2 years post RYGB and have regained >20% of their maximum lost weight and those who are >2 years post RYGB and have maintained at least 90% weight loss since surgery. The following specific aims will be evaluated:
Aim 1. Evaluate whether differences in eating behaviors exist between subjects who have maintained weight loss after RYGB or regained >20% of their maximum lost weight. The investigators hypothesize that subjects who have regained weight after RYGB will have higher scores on binge eating behaviors and an increased craving for sweets compared with patients who have maintained weight loss after RYGB. Eating behaviors will be determined by performing the Yale Food Addiction Scale (YFAS), Eating Disorder Examination (EDE), The Food Craving Inventory (FCI), and the National Cancer Institute (NCI) ASA24.
Aim 2. Evaluate whether differences exist in functional gastric volume between subjects who have maintained weight loss after RYGB or regained >20% of their maximum lost weight. The investigators hypothesize that patients who have regained weight after RYGB will have an increased functional gastric volume to both solids and liquids compared to subjects who have maintained weight loss after RYGB. Functional gastric volume will be measured during both a solid and liquid meal test.
Aim 3. Evaluate whether differences exist in gastric pouch and GJ sizes between subjects who have maintained weight loss after RYGB or regained >20% of their maximum lost weight. The investigators hypothesize that patients who have regained weight after RYGB will have increased gastric pouch size and GJ diameter compared with patients who have maintained their weight loss after RYGB. Anatomical dimensions of the gastric pouch and GJ will be determined by using an articulated measuring tool during upper GI tract endoscopy.
- Conditions
- Obesity
- Being tested
- Eating Behavior Evaluation, Measurement of Functional gastric volume, Measurement of gastric pouch and GJ size
- Keywords
- Roux-en-Y Gastric Bypass Surgery, Weight Regain
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eating Behavior EvaluationBehavioural
Also called Yale Food Addiction Scale (YFAS), Eating Disorder Examination (EDE), The Food Craving Inventory (FCI), National Cancer Institute (NCI) ASA24
Scores will be measured on binge eating behaviors and an increased craving for sweets.
Measurement of Functional gastric volumeOther
The functional gastric volume is the amount of food or liquid that can be consumed to a feeling of comfortably full in one meal.
Measurement of gastric pouch and GJ sizeOther
Anatomical dimensions of the gastric pouch and GJ will be determined by using an articulated measuring tool during upper GI tract endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Wt maintenance | Eating Behavior Evaluation Measurement of Functional gastric volume Measurement of gastric pouch and GJ sizes Receives: Behavioral: Eating Behavior Evaluation; Other: Measurement of Functional gastric volume; Other: Measurement of gastric pouch and GJ size | |
| Wt Regain | Eating Behavior Evaluation Measurement of Functional gastric volume Measurement of gastric pouch and GJ sizes Receives: Behavioral: Eating Behavior Evaluation; Other: Measurement of Functional gastric volume; Other: Measurement of gastric pouch and GJ size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Behavior Assessment scores will be compared between both groups
Eating behaviors will be determined by performing the Yale Food Addiction Scale (YFAS), Eating Disorder Examination (EDE), The Food Craving Inventory (FCI), and the National Cancer Institute (NCI) ASA24.
Measured: Greater than 2 years post RYGB
Secondary outcomes (2)
Functional gastric volume will be measured
The functional gastric volume is the amount of food or liquid that can be consumed to a feeling of comfortably full in one meal.
Measured: Greater than 2 years post RYGB
Gastric pouch size and GJ diameter will be measured
Anatomical dimensions of the gastric pouch and GJ will be determined by using an articulated measuring tool during upper GI tract endoscopy.
Measured: Greater than 2 years post RYGB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startOct 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shelby Sullivan, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302898
- Sponsor's protocol ID
- 201409107
- Status last verified
- Apr 2018
- First submitted
- 19 Nov 2014
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Pories WJ, Swanson MS, MacDonald KG, Long SB, Morris PG, Brown BM, Barakat HA, deRamon RA, Israel G, Dolezal JM, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg. 1995 Sep;222(3):339-50; discussion 350-2. doi: 10.1097/00000658-199509000-00011.
PubMed 7677463Magro DO, Geloneze B, Delfini R, Pareja BC, Callejas F, Pareja JC. Long-term weight regain after gastric bypass: a 5-year prospective study. Obes Surg. 2008 Jun;18(6):648-51. doi: 10.1007/s11695-007-9265-1. Epub 2008 Apr 8.
PubMed 18392907Brethauer SA, Aminian A, Romero-Talamas H, Batayyah E, Mackey J, Kennedy L, Kashyap SR, Kirwan JP, Rogula T, Kroh M, Chand B, Schauer PR. Can diabetes be surgically cured? Long-term metabolic effects of bariatric surgery in obese patients with type 2 diabetes mellitus. Ann Surg. 2013 Oct;258(4):628-36; discussion 636-7. doi: 10.1097/SLA.0b013e3182a5034b.
PubMed 24018646Freire RH, Borges MC, Alvarez-Leite JI, Toulson Davisson Correia MI. Food quality, physical activity, and nutritional follow-up as determinant of weight regain after Roux-en-Y gastric bypass. Nutrition. 2012 Jan;28(1):53-8. doi: 10.1016/j.nut.2011.01.011. Epub 2011 Aug 31.
PubMed 21885246Schultes B, Ernst B, Wilms B, Thurnheer M, Hallschmid M. Hedonic hunger is increased in severely obese patients and is reduced after gastric bypass surgery. Am J Clin Nutr. 2010 Aug;92(2):277-83. doi: 10.3945/ajcn.2009.29007. Epub 2010 Jun 2.
PubMed 20519559Miras AD, Jackson RN, Jackson SN, Goldstone AP, Olbers T, Hackenberg T, Spector AC, le Roux CW. Gastric bypass surgery for obesity decreases the reward value of a sweet-fat stimulus as assessed in a progressive ratio task. Am J Clin Nutr. 2012 Sep;96(3):467-73. doi: 10.3945/ajcn.112.036921. Epub 2012 Jul 25.
PubMed 22836034Pepino MY, Bradley D, Eagon JC, Sullivan S, Abumrad NA, Klein S. Changes in taste perception and eating behavior after bariatric surgery-induced weight loss in women. Obesity (Silver Spring). 2014 May;22(5):E13-20. doi: 10.1002/oby.20649. Epub 2013 Dec 6.
PubMed 24167016Hsu LK, Betancourt S, Sullivan SP. Eating disturbances before and after vertical banded gastroplasty: a pilot study. Int J Eat Disord. 1996 Jan;19(1):23-34. doi: 10.1002/(SICI)1098-108X(199601)19:13.0.CO;2-Y.
PubMed 8640199White MA, Kalarchian MA, Masheb RM, Marcus MD, Grilo CM. Loss of control over eating predicts outcomes in bariatric surgery patients: a prospective, 24-month follow-up study. J Clin Psychiatry. 2010 Feb;71(2):175-84. doi: 10.4088/JCP.08m04328blu. Epub 2009 Oct 20.
PubMed 19852902Saunders R. "Grazing": a high-risk behavior. Obes Surg. 2004 Jan;14(1):98-102. doi: 10.1381/096089204772787374.
PubMed 14980042Christou NV, Look D, Maclean LD. Weight gain after short- and long-limb gastric bypass in patients followed for longer than 10 years. Ann Surg. 2006 Nov;244(5):734-40. doi: 10.1097/01.sla.0000217592.04061.d5.
PubMed 17060766Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.
PubMed 15616203Franco JV, Ruiz PA, Palermo M, Gagner M. A review of studies comparing three laparoscopic procedures in bariatric surgery: sleeve gastrectomy, Roux-en-Y gastric bypass and adjustable gastric banding. Obes Surg. 2011 Sep;21(9):1458-68. doi: 10.1007/s11695-011-0390-5.
PubMed 21455833Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
PubMed 15479938Hall JC, Watts JM, O'Brien PE, Dunstan RE, Walsh JF, Slavotinek AH, Elmslie RG. Gastric surgery for morbid obesity. The Adelaide Study. Ann Surg. 1990 Apr;211(4):419-27. doi: 10.1097/00000658-199004000-00007.
PubMed 2181950
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics Associated With Weight Regain After Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT02302898
- Acronym / sponsor ID
- 201409107
- Conditions
- Obesity
- Keywords
- Roux-en-Y Gastric Bypass Surgery, Weight Regain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Nov 2014 (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.
This study compares eating behaviors, meal size, and the size of the gastric pouch and connection between the gastric pouch and small intestine in patients who had gastric bypass surgery two or more years ago and regained weight compared with patients who had gastric bypass surgery two or more years ago and maintained their weight loss.
Detailed description
Obesity affects a third of adults in the United States. The most effective treatment for weight loss is bariatric surgery, and the most common surgery performed in the US is Roux-en-Y Gastric Bypass (RYGB). However, a significant number of patients regain weight that was lost after surgery. The mechanisms for weight regain are likely multifactorial, but not well understood. Disordered eating behaviors and dilated gastrojejunostomies (GJ), which presumably allows a patient to consume larger portion sizes during a meal, correlate with weight regain. Moreover, some data suggest that changes to the gut anatomy may drive eating behaviors and food preferences. However, no studies have simultaneously evaluated functional gastric volume (the volume of solid or liquid food that can be consumed to a level of comfortable fullness in one sitting), anatomical gastric pouch size and GJ diameter, and eating behaviors in patients who maintained their post RYGB weight compared with patients who have regained weight from their maximum weight loss after RYGB to determine the relationship among post RYGB eating behavior, functional and anatomical gastric pouch size, GJ diameter and weight change. Accordingly, the objectives of this proposal are to compare 1) eating behaviors 2) functional gastric volume and 3) anatomical dimensions of the gastric pouch and GJ in patients who are >2 years post RYGB and have regained >20% of their maximum lost weight and those who are >2 years post RYGB and have maintained at least 90% weight loss since surgery. The following specific aims will be evaluated:
Aim 1. Evaluate whether differences in eating behaviors exist between subjects who have maintained weight loss after RYGB or regained >20% of their maximum lost weight. The investigators hypothesize that subjects who have regained weight after RYGB will have higher scores on binge eating behaviors and an increased craving for sweets compared with patients who have maintained weight loss after RYGB. Eating behaviors will be determined by performing the Yale Food Addiction Scale (YFAS), Eating Disorder Examination (EDE), The Food Craving Inventory (FCI), and the National Cancer Institute (NCI) ASA24.
Aim 2. Evaluate whether differences exist in functional gastric volume between subjects who have maintained weight loss after RYGB or regained >20% of their maximum lost weight. The investigators hypothesize that patients who have regained weight after RYGB will have an increased functional gastric volume to both solids and liquids compared to subjects who have maintained weight loss after RYGB. Functional gastric volume will be measured during both a solid and liquid meal test.
Aim 3. Evaluate whether differences exist in gastric pouch and GJ sizes between subjects who have maintained weight loss after RYGB or regained >20% of their maximum lost weight. The investigators hypothesize that patients who have regained weight after RYGB will have increased gastric pouch size and GJ diameter compared with patients who have maintained their weight loss after RYGB. Anatomical dimensions of the gastric pouch and GJ will be determined by using an articulated measuring tool during upper GI tract endoscopy.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wt maintenance | – | Behavioral: Eating Behavior Evaluation, Other: Measurement of Functional gastric volume, Other: Measurement of gastric pouch and GJ sizeEating Behavior Evaluation Measurement of Functional gastric volume Measurement of gastric pouch and GJ sizes |
| Wt Regain | – | Behavioral: Eating Behavior Evaluation, Other: Measurement of Functional gastric volume, Other: Measurement of gastric pouch and GJ sizeEating Behavior Evaluation Measurement of Functional gastric volume Measurement of gastric pouch and GJ sizes |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will consist of 20 patients who had laparoscopic RYGB surgery >2 years before screening and have regained >20% weight from their maximum weight lost after surgery and 20 patients who had laparoscopic RYGB surgery >2 years before screening and have maintained at least 90% weight loss from the maximum weight loss after surgery. These patients will be identified from the bariatric surgical population at Washington University School of Medicine.
Key inclusion criteria (3 listed)
- Ages of 21 and 60
- Laparoscopic RYGB surgery >2 years before screening
- Regained >20% weight from their maximum weight lost after surgery or maintained at least 90% weight loss from the maximum weight loss after surgery
Key exclusion criteria (15 listed)
- Allergy to lidocaine, nut allergies, milk intolerance or any other food allergies/restrictions that are included in our test meals
- A history of alcohol abuse
- Currently consuming >20 gm of alcohol per day
- Greater than 2 points on the MAST
- Severe organ dysfunction
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 |
|---|---|---|
| Eating Behavior EvaluationAlso: Yale Food Addiction Scale (YFAS), Eating Disorder Examination (EDE), The Food Craving Inventory (FCI), National Cancer Institute (NCI) ASA24Scores will be measured on binge eating behaviors and an increased craving for sweets. | Behavioural | Wt Regain, Wt maintenance |
| Measurement of Functional gastric volumeThe functional gastric volume is the amount of food or liquid that can be consumed to a feeling of comfortably full in one meal. | Other | Wt Regain, Wt maintenance |
| Measurement of gastric pouch and GJ sizeAnatomical dimensions of the gastric pouch and GJ will be determined by using an articulated measuring tool during upper GI tract endoscopy. | Other | Wt Regain, Wt maintenance |
Primary outcome
Eating Behavior Assessment scores will be compared between both groups
Time frame: Greater than 2 years post RYGB
Eating behaviors will be determined by performing the Yale Food Addiction Scale (YFAS), Eating Disorder Examination (EDE), The Food Craving Inventory (FCI), and the National Cancer Institute (NCI) ASA24.
2 secondary outcomes
Functional gastric volume will be measured
Time frame: Greater than 2 years post RYGB
Gastric pouch size and GJ diameter will be measured
Time frame: Greater than 2 years post RYGB
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 9 Apr 2018.
- Background: PubMed 7677463Pories WJ, Swanson MS, MacDonald KG, Long SB, Morris PG, Brown BM, Barakat HA, deRamon RA, Israel G, Dolezal JM, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg. 1995 Sep;222(3):339-50; discussion 350-2. doi: 10.1097/00000658-199509000-00011.
- Background: PubMed 18392907Magro DO, Geloneze B, Delfini R, Pareja BC, Callejas F, Pareja JC. Long-term weight regain after gastric bypass: a 5-year prospective study. Obes Surg. 2008 Jun;18(6):648-51. doi: 10.1007/s11695-007-9265-1. Epub 2008 Apr 8.
- Background: PubMed 24018646Brethauer SA, Aminian A, Romero-Talamas H, Batayyah E, Mackey J, Kennedy L, Kashyap SR, Kirwan JP, Rogula T, Kroh M, Chand B, Schauer PR. Can diabetes be surgically cured? Long-term metabolic effects of bariatric surgery in obese patients with type 2 diabetes mellitus. Ann Surg. 2013 Oct;258(4):628-36; discussion 636-7. doi: 10.1097/SLA.0b013e3182a5034b.
- Background: PubMed 21885246Freire RH, Borges MC, Alvarez-Leite JI, Toulson Davisson Correia MI. Food quality, physical activity, and nutritional follow-up as determinant of weight regain after Roux-en-Y gastric bypass. Nutrition. 2012 Jan;28(1):53-8. doi: 10.1016/j.nut.2011.01.011. Epub 2011 Aug 31.
- Background: PubMed 20519559Schultes B, Ernst B, Wilms B, Thurnheer M, Hallschmid M. Hedonic hunger is increased in severely obese patients and is reduced after gastric bypass surgery. Am J Clin Nutr. 2010 Aug;92(2):277-83. doi: 10.3945/ajcn.2009.29007. Epub 2010 Jun 2.
- Background: PubMed 22836034Miras AD, Jackson RN, Jackson SN, Goldstone AP, Olbers T, Hackenberg T, Spector AC, le Roux CW. Gastric bypass surgery for obesity decreases the reward value of a sweet-fat stimulus as assessed in a progressive ratio task. Am J Clin Nutr. 2012 Sep;96(3):467-73. doi: 10.3945/ajcn.112.036921. Epub 2012 Jul 25.
- Background: PubMed 24167016Pepino MY, Bradley D, Eagon JC, Sullivan S, Abumrad NA, Klein S. Changes in taste perception and eating behavior after bariatric surgery-induced weight loss in women. Obesity (Silver Spring). 2014 May;22(5):E13-20. doi: 10.1002/oby.20649. Epub 2013 Dec 6.
- Background: PubMed 8640199Hsu LK, Betancourt S, Sullivan SP. Eating disturbances before and after vertical banded gastroplasty: a pilot study. Int J Eat Disord. 1996 Jan;19(1):23-34. doi: 10.1002/(SICI)1098-108X(199601)19:13.0.CO;2-Y.
- Background: PubMed 19852902White MA, Kalarchian MA, Masheb RM, Marcus MD, Grilo CM. Loss of control over eating predicts outcomes in bariatric surgery patients: a prospective, 24-month follow-up study. J Clin Psychiatry. 2010 Feb;71(2):175-84. doi: 10.4088/JCP.08m04328blu. Epub 2009 Oct 20.
- Background: PubMed 14980042Saunders R. "Grazing": a high-risk behavior. Obes Surg. 2004 Jan;14(1):98-102. doi: 10.1381/096089204772787374.
- Results publication: PubMed 17060766Christou NV, Look D, Maclean LD. Weight gain after short- and long-limb gastric bypass in patients followed for longer than 10 years. Ann Surg. 2006 Nov;244(5):734-40. doi: 10.1097/01.sla.0000217592.04061.d5.
- Results publication: PubMed 15616203Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.
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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.
Shelby Sullivan, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Washington University School of Medicine 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 3 inclusion and 15 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 9 Apr 2018. 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?
Eating Behavior Assessment scores will be compared between both groups (time frame: Greater than 2 years post RYGB). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02302898, which also lists 42 linked publications.
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 9 Apr 2018.