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

This study has been completed.
Sponsor:
Collaborators:
EndoVx, Inc.
University of California, San Francisco
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00285220
First received: January 31, 2006
Last updated: February 17, 2009
Last verified: February 2009
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014