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

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

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of Laparoscopic Truncal Vagotomy for the Treatment of Obesity

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Obesity Weight Control

U.S. FDA Resources

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
Study Completion Date:	December 2008

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00285220 History of Changes
Other Study ID Numbers:	00011552
Study First Received:	January 31, 2006
Last Updated:	February 17, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 12, 2012