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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric Bypass | morbidly obese subjects undergoing gastric bypass surgery |
| |
| Gastric banding | morbidly obese subjects undergoing laparoscopic gastric banding surgery |
| |
| Sleeve gastrectomy | morbidly obese subjects undergoing sleeve gastrectomy surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric bypass | Procedure | Roux-en-Y gastric bypass |
| |
| Gastric banding |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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A total of 41 morbidly obese (BMI>=35 kg/m²) subjects scheduled for bariatric surgical procedures will participate in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Klein, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gastric Bypass | morbidly obese subjects undergoing gastric bypass surgery Gastric bypass: Roux-en-Y gastric bypass |
| FG001 | Gastric Banding | morbidly obese subjects undergoing laparoscopic gastric banding surgery Gastric banding: Laparoscopic adjustable gastric banding |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gastric Bypass | morbidly obese subjects undergoing gastric bypass surgery Gastric bypass: Roux-en-Y gastric bypass |
| BG001 | Gastric Banding | morbidly obese subjects undergoing laparoscopic gastric banding surgery Gastric banding: Laparoscopic adjustable gastric banding |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Median | Inter-Quartile Range | mmol/L | 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 |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gastric Bypass | morbidly obese subjects undergoing gastric bypass surgery Gastric bypass: Roux-en-Y gastric bypass |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M. Yanina Pepino | University of Illinois at Urbana Champaign | 217-300-2374 | ypepino@illinois.edu |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
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Tongue tissue
| Procedure |
Laparoscopic adjustable gastric banding |
|
| Sleeve gastrectomy | Procedure | Sleeve gastrectomy surgery |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body weight before surgery | Mean | Standard Deviation | Kg |
|
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | 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 |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Gastric Banding | morbidly obese subjects undergoing laparoscopic gastric banding surgery Gastric banding: Laparoscopic adjustable gastric banding | 0 | 10 | 0 | 10 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D005763 |
| Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |
| Cravings for fast food before surgery |
|
| Cravings for fast food after surgery |
|
| Cravings for high fat food before surgery |
|
| Cravings for high fat food after surgery |
|
| Cravings for starchy food before surgery |
|
| Cravings for starchy food after surgery |
|
| Restrained eating before surgery |
|
| Restrained eating after surgery |
|
| Emotional eating before surgery |
|
| Emotional eating after surgery |
|
| External eating before surgery |
|
| External eating after surgery |
|