Morbid ObesityRBtasteNCT01536197
Taste Perception Pre and Post Bariatric Surgery
An observational study of Morbid Obesity, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The investigators wish to study the effects of three forms of bariatric surgery, gastric bypass lap banding, and sleeve gastrectomy. The surgery is not part of the clinical trial. If your insurance does not cover the procedure, then the patient is responsible for payment of the surgical process. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Gastric bypass, Gastric banding and Sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jun 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 41 morbidly obese (BMI>=35 kg/m²) subjects scheduled for bariatric surgical procedures will participate in this study.
Who may be able to join
- BMI >=35 kg/m²
- on stable dose of medication for at least 4 weeks before the pre-surgery studies
- women
Who cannot join
- smokes > 7 cigarettes per day
- previous malabsorptive or restrictive intestinal surgery
- pregnant or breastfeeding
- recent history of neoplasia (< 5 years ago)
- have malabsorptive syndromes and inflammatory intestinal disease
- diabetes mellitus
Show all 10Show fewer
- show signs of oral disease or xerostomia (i.e. dry mouth)
- history of chronic rhinitis
- on medication that might affect taste
- severe organ disfunction
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: Effect of Bariatric Surgery-induced Weight Loss on Taste Perception
The investigators wish to study the effects of three forms of bariatric surgery, gastric bypass lap banding, and sleeve gastrectomy. The surgery is not part of the clinical trial. If your insurance does not cover the procedure, then the patient is responsible for payment of the surgical process. The investigators are doing pre and post surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight-loss on taste perception.
Read the detailed description
Bariatric surgery is the most effective weight loss therapy for obesity. However, the mechanisms responsible for decreased food intake are incompletely understood. One possible mechanism that could account for decreased food intake is changes in taste perception. Therefore, the primary goal of this proposal is to provide a better understanding of the effects of bariatric surgery-induced weight-loss on taste perception.
- Conditions
- Morbid Obesity
- Being tested
- Gastric bypass, Gastric banding, Sleeve gastrectomy
- Keywords
- obesity, gastric bypass, gastric banding, sleeve gastrectomy, weight loss, taste perception
- Medical subject headings
- Obesity, Morbid, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric bypassProcedure or surgery
Roux-en-Y gastric bypass
Gastric bandingProcedure or surgery
Laparoscopic adjustable gastric banding
Sleeve gastrectomyProcedure or surgery
Sleeve gastrectomy surgery
| Study group | Role | What they receive |
|---|---|---|
| Gastric Bypass | morbidly obese subjects undergoing gastric bypass surgery Receives: Procedure: Gastric bypass | |
| Gastric banding | morbidly obese subjects undergoing laparoscopic gastric banding surgery Receives: Procedure: Gastric banding | |
| Sleeve gastrectomy | morbidly obese subjects undergoing sleeve gastrectomy surgery Receives: Procedure: Sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on Taste Detection Thresholds After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Banding).
-Taste detection thresholds measures the lowest concentration of a tastant that can be detected (mili molar amounts).
Measured: we will measure the above outcomes before surgery and at 20% weight loss post surgery, which on average we expect will occur around 3 months post-surgery
Secondary outcomes (1)
Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).
-Eating behavior will be measured with validated questionnaires including among others the Dutch Eating Behavior Questionnaire (DEBQ) and the Food Craving Inventory (FCI). The DEBQ measures three common psychological dimensions of eating behavior: 1) emotional eating , 2) external eating (an inclination to eat in response to external food cues such as the smell and taste of food), and 3) restrained eating (an inclination to consciously restrict food intake to control body weight). The FCI is a validated measure of the frequency of overall food cravings as well as cravings for specific types of foods (high fats, sweets, carbohydrates/ starches, and fast-food fats) during the past month. For the DEBQ and the FCI, subjects score their answers by using a 5-point Likert scale (1=never, 5=very often/always).Therefore, lower numbers means having less frequent food cravings (for FCI), or engaging less frequently in the particular type of eating behavior (for DEBQ).
Measured: we will measure the above outcomes before surgery and at 20% weight loss post surgery, which on average we expect will occur around 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startSep 2009
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Morbid 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Klein, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536197
- Sponsor's protocol ID
- 09-0175B
- Acronym
- RBtaste
- Status last verified
- Nov 2017
- First submitted
- 9 Feb 2012
- Last updated
- 18 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bariatric Surgery-induced Weight Loss on Taste Perception
- ClinicalTrials.gov ID
- NCT01536197
- Acronym / sponsor ID
- RBtaste / 09-0175B
- Conditions
- Morbid Obesity
- Keywords
- obesity, gastric bypass, gastric banding, sleeve gastrectomy, weight loss, taste perception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Sep 2009 (actual)
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Feb 2012 (estimated)
- Results
- Posted 3 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators wish to study the effects of three forms of bariatric surgery, gastric bypass lap banding, and sleeve gastrectomy. The surgery is not part of the clinical trial. If your insurance does not cover the procedure, then the patient is responsible for payment of the surgical process. The investigators are doing pre and post surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight-loss on taste perception.
Detailed description
Bariatric surgery is the most effective weight loss therapy for obesity. However, the mechanisms responsible for decreased food intake are incompletely understood. One possible mechanism that could account for decreased food intake is changes in taste perception. Therefore, the primary goal of this proposal is to provide a better understanding of the effects of bariatric surgery-induced weight-loss on taste perception.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gastric Bypass | – | Procedure: Gastric bypassmorbidly obese subjects undergoing gastric bypass surgery |
| Gastric banding | – | Procedure: Gastric bandingmorbidly obese subjects undergoing laparoscopic gastric banding surgery |
| Sleeve gastrectomy | – | Procedure: Sleeve gastrectomymorbidly obese subjects undergoing sleeve gastrectomy surgery |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 41 morbidly obese (BMI>=35 kg/m²) subjects scheduled for bariatric surgical procedures will participate in this study.
Key inclusion criteria (3 listed)
- BMI >=35 kg/m²
- on stable dose of medication for at least 4 weeks before the pre-surgery studies
- women
Key exclusion criteria (10 listed)
- smokes > 7 cigarettes per day
- previous malabsorptive or restrictive intestinal surgery
- pregnant or breastfeeding
- recent history of neoplasia (< 5 years ago)
- have malabsorptive syndromes and inflammatory intestinal disease
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 |
|---|---|---|
| Gastric bypassRoux-en-Y gastric bypass | Procedure or surgery | Gastric Bypass |
| Gastric bandingLaparoscopic adjustable gastric banding | Procedure or surgery | Gastric banding |
| Sleeve gastrectomySleeve gastrectomy surgery | Procedure or surgery | Sleeve gastrectomy |
Primary outcome
Changes on Taste Detection Thresholds After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Banding).
Time frame: we will measure the above outcomes before surgery and at 20% weight loss post surgery, which on average we expect will occur around 3 months post-surgery
-Taste detection thresholds measures the lowest concentration of a tastant that can be detected (mili molar amounts).
1 secondary outcome
Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).
Time frame: we will measure the above outcomes before surgery and at 20% weight loss post surgery, which on average we expect will occur around 3 months post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Morbid Obesity
RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
RecruitingPhase 3
A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
Monogenic Obesity
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
Enrolling by invitation
Biometabolic Outcomes After Weight Loss Surgery: An Individualized Approach
Obesity, Morbid, Metabolic Syndrome
RecruitingPhase 4
Impact GLP-1 Agonists Following Bariatric
Morbid Obesity, Metabolic Syndrome
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.
Samuel Klein, M.D. 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 Morbid 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 10 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 18 Dec 2017. 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?
Yes. Results are posted in the registry (first posted 3 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes on Taste Detection Thresholds After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Banding). (time frame: we will measure the above outcomes before surgery and at 20% weight loss post surgery, which on average we expect will occur around 3 months post-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 18 Dec 2017.