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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01536197
Other study ID # 09-0175B
Secondary ID
Status Completed
Phase N/A
First received February 9, 2012
Last updated November 6, 2017
Start date September 2009
Est. completion date June 2013

Study information

Verified date November 2017
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date June 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Gastric bypass
Roux-en-Y gastric bypass
Gastric banding
Laparoscopic adjustable gastric banding
Sleeve gastrectomy
Sleeve gastrectomy surgery

Locations

Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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). 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 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). 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
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