NCT01536197

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 3, 2014

Completed
Last Updated

December 18, 2017

Status Verified

November 1, 2017

Enrollment Period

3.7 years

First QC Date

February 9, 2012

Results QC Date

June 2, 2014

Last Update Submit

November 6, 2017

Conditions

Morbid Obesity

Keywords

obesitygastric bypassgastric bandingsleeve gastrectomyweight losstaste perception

Outcome Measures

Primary Outcomes (1)

  • 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 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).

    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

Study Arms (3)

Gastric Bypass

morbidly obese subjects undergoing gastric bypass surgery

Procedure: Gastric bypass

Gastric banding

morbidly obese subjects undergoing laparoscopic gastric banding surgery

Procedure: Gastric banding

Sleeve gastrectomy

morbidly obese subjects undergoing sleeve gastrectomy surgery

Procedure: Sleeve gastrectomy

Interventions

Gastric bypassPROCEDURE

Roux-en-Y gastric bypass

Gastric Bypass
Gastric bandingPROCEDURE

Laparoscopic adjustable gastric banding

Gastric banding
Sleeve gastrectomyPROCEDURE

Sleeve gastrectomy surgery

Sleeve gastrectomy

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 41 morbidly obese (BMI\>=35 kg/m²) subjects scheduled for bariatric surgical procedures will participate in this study.

You may qualify if:

  • BMI \>=35 kg/m²
  • on stable dose of medication for at least 4 weeks before the pre-surgery studies
  • women

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tongue tissue

MeSH Terms

Conditions

Obesity, MorbidObesityWeight Loss

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Results Point of Contact

Title
M. Yanina Pepino
Organization
University of Illinois at Urbana Champaign
ypepino@illinois.edu
217-300-2374

Study Officials

  • Samuel Klein, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2012

First Posted

February 20, 2012

Study Start

September 1, 2009

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

December 18, 2017

Results First Posted

July 3, 2014

Record last verified: 2017-11

Locations

US(1)