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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00285220
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : February 19, 2009
Sponsor:
Collaborators:
Information provided by:

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.

Condition or disease Intervention/treatment
Morbid Obesity Procedure: Laparoscopic Truncal Vagotomy

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2005
Study Completion Date : December 2008
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Percent Excess Weight Loss
  2. Absolute Weight Loss
  3. Change in BMI
  4. Change in Percent Body Fat (DEXA)
  5. Change in Percent Body Fat (Impedence)
  6. Change in Lipid Panel (chol, triglycerides, LDL, HDL
  7. Urinary pH
  8. 3 day dietary diary
  9. fasting glucose
  10. OGGT with insulin
  11. OGGT with FFA and gut peptides
  12. gastric emptying

Secondary Outcome Measures :
  1. adverse events

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00285220     History of Changes
Other Study ID Numbers: 00011552
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: February 19, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms