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

Purpose

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.

Condition	Intervention
Morbid Obesity	Procedure: Laparoscopic Truncal Vagotomy

MedlinePlus related topics:

Obesity

U.S. FDA Resources

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

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

Further study details as provided by University of Rochester:

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

Estimated Enrollment:	30
Study Start Date:	September 2005
Estimated Study Completion Date:	April 2007

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.

Eligibility

Ages Eligible for Study:	25 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285220

Locations


United States, California
	University of California at San Francisco, Dept of Pediatrics
	San Francisco, California, United States, 94143

United States, New York
	Strong Health Bariatric Center at Highland Hospital
	Rochester, New York, United States, 14624

Sponsors and Collaborators

University of Rochester

EndoVx, Inc.

University of California, San Francisco

Investigators


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

More Information

Study ID Numbers:	00011552
First Received:	January 31, 2006
Last Updated:	April 17, 2007
ClinicalTrials.gov Identifier:	NCT00285220
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Nutrition Disorders

Overweight

Overnutrition

Obesity, Morbid

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	University of Rochester EndoVx, Inc. University of California, San Francisco
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00285220