Safety and Efficacy of Laparoscopic Truncal Vagotomy for the Treatment of Obesity
This study has been completed.
Sponsor:
University of Rochester
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
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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 |
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 June 18, 2013