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Safety and Efficacy of Laparoscopic Truncal Vagotomy for the Treatment of Obesity

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laparoscopic Truncal Vagotomy
Sponsored by
University of Rochester
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: male or female age 25-55 BMI 35-40 with comorbidity and BMI 40-45 with or without comorbidity Stable weight for the last 3 months willing to use contraceptives motivated to lose weight a personal history of at least one professionally supervised 6 month attempt or more than 2 serious attempts to loose weight fully ambulatory Exclusion Criteria: sign of prior major abdominal surgery history of or signs and /or symptoms of gastro-duodenal ulcer disease abnormal vagus nerve testing current use of a list of medication

Sites / Locations

  • University of California at San Francisco, Dept of Pediatrics
  • Strong Health Bariatric Center at Highland Hospital

Outcomes

Primary Outcome Measures

Percent Excess Weight Loss
Absolute Weight Loss
Change in BMI
Change in Percent Body Fat (DEXA)
Change in Percent Body Fat (Impedence)
Change in Lipid Panel (chol, triglycerides, LDL, HDL
Urinary pH
3 day dietary diary
fasting glucose
OGGT with insulin
OGGT with FFA and gut peptides
gastric emptying

Secondary Outcome Measures

adverse events

Full Information

First Posted
January 31, 2006
Last Updated
February 17, 2009
Sponsor
University of Rochester
Collaborators
EndoVx, Inc., University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00285220
Brief Title
Safety and Efficacy of Laparoscopic Truncal Vagotomy for the Treatment of Obesity
Official Title
A Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of Laparoscopic Truncal Vagotomy for the Treatment of Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Rochester
Collaborators
EndoVx, Inc., University of California, San Francisco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This two site study will evaluate the safety and effectiveness of laparoscopic truncal vagotomy for the treatment of obesity with baseline study and 18 month post op follow up.
Detailed Description
30 morbidly obese patients evenly enrolled at The University of California San Francisco and at the University of Rochester will be selected for study on a voluntary basis. They will have a BMI of >35 with at least one obesity related comorbidity or a BMI between 40 and 45. Subjects will undergo specific tests of vagal function and baseline metabolic evaluation at baseline. Thereafter they will undergo a laparoscopic truncal vagotomy. Over 18 months, post operative tests of adequate vagotomy, weight loss, change in body composition and metabolism will be studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Truncal Vagotomy
Primary Outcome Measure Information:
Title
Percent Excess Weight Loss
Title
Absolute Weight Loss
Title
Change in BMI
Title
Change in Percent Body Fat (DEXA)
Title
Change in Percent Body Fat (Impedence)
Title
Change in Lipid Panel (chol, triglycerides, LDL, HDL
Title
Urinary pH
Title
3 day dietary diary
Title
fasting glucose
Title
OGGT with insulin
Title
OGGT with FFA and gut peptides
Title
gastric emptying
Secondary Outcome Measure Information:
Title
adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: male or female age 25-55 BMI 35-40 with comorbidity and BMI 40-45 with or without comorbidity Stable weight for the last 3 months willing to use contraceptives motivated to lose weight a personal history of at least one professionally supervised 6 month attempt or more than 2 serious attempts to loose weight fully ambulatory Exclusion Criteria: sign of prior major abdominal surgery history of or signs and /or symptoms of gastro-duodenal ulcer disease abnormal vagus nerve testing current use of a list of medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Lustig, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marco Pattti, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thad Boss, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California at San Francisco, Dept of Pediatrics
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Strong Health Bariatric Center at Highland Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14624
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Laparoscopic Truncal Vagotomy for the Treatment of Obesity

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