Safety and Efficacy of Laparoscopic Truncal Vagotomy for the Treatment of Obesity - Tabular View

Tracking Information

First Received Date ^ICMJE

January 31, 2006

Last Updated Date

February 17, 2009

Start Date ^ICMJE

September 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00285220 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

adverse events

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of Laparoscopic Truncal Vagotomy for the Treatment of Obesity

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Morbid Obesity

Intervention ^ICMJE

Procedure: Laparoscopic Truncal Vagotomy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

25 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00285220

Responsible Party

Study ID Numbers ^ICMJE

00011552

Study Sponsor ^ICMJE

University of Rochester

Collaborators ^ICMJE

EndoVx, Inc.
University of California, San Francisco

Investigators ^ICMJE

Principal Investigator:	Robert Lustig, MD	University of California, San Francisco
Principal Investigator:	Marco Pattti, MD	University of California, San Francisco
Principal Investigator:	Thad Boss, MD	University of Rochester

Information Provided By

University of Rochester

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP