Morbid Obesity
Conditions
Keywords
obesity, gastric bypass, gastric banding, sleeve gastrectomy, weight loss, taste perception
Brief 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. 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.
Interventions
PROCEDUREGastric bypass
Roux-en-Y gastric bypass
PROCEDUREGastric banding
Laparoscopic adjustable gastric banding
PROCEDURESleeve gastrectomy
Sleeve gastrectomy surgery
Sponsors
Washington University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* BMI \>=35 kg/m² * on stable dose of medication for at least 4 weeks before the pre-surgery studies * women
Exclusion criteria
* 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 signs of oral disease or xerostomia (i.e. dry mouth) * history of chronic rhinitis * on medication that might affect taste * severe organ disfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes on Taste Detection Thresholds After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Banding). | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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 | -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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gastric Bypass morbidly obese subjects undergoing gastric bypass surgery
Gastric bypass: Roux-en-Y gastric bypass | 23 |
| Gastric Banding morbidly obese subjects undergoing laparoscopic gastric banding surgery
Gastric banding: Laparoscopic adjustable gastric banding | 10 |
| Total | 33 |
Baseline characteristics
| Characteristic | Gastric Bypass | Gastric Banding | Total |
|---|---|---|---|
| Age, Continuous | 43.0 years STANDARD_DEVIATION 9.6 | 46.8 years STANDARD_DEVIATION 13.9 | 43.5 years STANDARD_DEVIATION 10.2 |
| Body weight before surgery | 129.8 Kg STANDARD_DEVIATION 26.1 | 127.1 Kg STANDARD_DEVIATION 31 | 128.7 Kg STANDARD_DEVIATION 27.2 |
| Sex: Female, Male Female | 20 Participants | 10 Participants | 30 Participants |
| Sex: Female, Male Male | 3 Participants | 0 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 10 |
| serious Total, serious adverse events | 0 / 23 | 0 / 10 |
Outcome results
Primary
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).
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gastric Bypass | Changes on Taste Detection Thresholds After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Banding). | Sucrose taste detection threshold before surgery | 7.5 mmol/L |
| Gastric Bypass | Changes on Taste Detection Thresholds After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Banding). | Sucrose taste detection threshold after surgery | 6.5 mmol/L |
| Gastric Banding | Changes on Taste Detection Thresholds After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Banding). | Sucrose taste detection threshold before surgery | 8.1 mmol/L |
| Gastric Banding | Changes on Taste Detection Thresholds After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Banding). | Sucrose taste detection threshold after surgery | 7.5 mmol/L |
p-value: 0.19ANOVA
Secondary
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).
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gastric Bypass | 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). | Cravings for sweets before surgery | 2.3 units on a scale | Standard Deviation 0.8 |
| Gastric Bypass | 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). | Cravings for sweets after surgery | 1.6 units on a scale | Standard Deviation 0.6 |
| Gastric Bypass | 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). | Cravings for fast food before surgery | 2.9 units on a scale | Standard Deviation 0.7 |
| Gastric Bypass | 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). | Cravings for fast food after surgery | 2.2 units on a scale | Standard Deviation 0.6 |
| Gastric Bypass | 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). | Cravings for high fat food before surgery | 2.2 units on a scale | Standard Deviation 0.7 |
| Gastric Bypass | 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). | Cravings for high fat food after surgery | 1.8 units on a scale | Standard Deviation 0.6 |
| Gastric Bypass | 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). | Cravings for starchy food before surgery | 2.2 units on a scale | Standard Deviation 0.8 |
| Gastric Bypass | 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). | Cravings for starchy food after surgery | 1.9 units on a scale | Standard Deviation 0.7 |
| Gastric Bypass | 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). | Restrained eating before surgery | 2.9 units on a scale | Standard Deviation 0.6 |
| Gastric Bypass | 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). | Restrained eating after surgery | 3.0 units on a scale | Standard Deviation 0.7 |
| Gastric Bypass | 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). | Emotional eating before surgery | 2.6 units on a scale | Standard Deviation 0.9 |
| Gastric Bypass | 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). | Emotional eating after surgery | 1.8 units on a scale | Standard Deviation 0.7 |
| Gastric Bypass | 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). | External eating before surgery | 3.0 units on a scale | Standard Deviation 0.5 |
| Gastric Bypass | 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). | External eating after surgery | 2.2 units on a scale | Standard Deviation 0.5 |
| Gastric Banding | 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). | Emotional eating before surgery | 3.2 units on a scale | Standard Deviation 1 |
| Gastric Banding | 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). | Cravings for sweets before surgery | 2.7 units on a scale | Standard Deviation 0.7 |
| Gastric Banding | 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). | Cravings for starchy food after surgery | 1.9 units on a scale | Standard Deviation 0.6 |
| Gastric Banding | 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). | Cravings for sweets after surgery | 2.3 units on a scale | Standard Deviation 0.5 |
| Gastric Banding | 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). | External eating before surgery | 3.4 units on a scale | Standard Deviation 0.5 |
| Gastric Banding | 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). | Cravings for fast food before surgery | 2.6 units on a scale | Standard Deviation 0.8 |
| Gastric Banding | 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). | Restrained eating before surgery | 2.8 units on a scale | Standard Deviation 0.5 |
| Gastric Banding | 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). | Cravings for fast food after surgery | 2.2 units on a scale | Standard Deviation 0.5 |
| Gastric Banding | 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). | Emotional eating after surgery | 2.3 units on a scale | Standard Deviation 1 |
| Gastric Banding | 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). | Cravings for high fat food before surgery | 2.0 units on a scale | Standard Deviation 0.8 |
| Gastric Banding | 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). | Restrained eating after surgery | 3.4 units on a scale | Standard Deviation 1 |
| Gastric Banding | 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). | Cravings for high fat food after surgery | 1.9 units on a scale | Standard Deviation 0.7 |
| Gastric Banding | 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). | External eating after surgery | 2.4 units on a scale | Standard Deviation 0.6 |
| Gastric Banding | 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). | Cravings for starchy food before surgery | 2.2 units on a scale | Standard Deviation 0.5 |