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Completed

NCT Number: NCT00285220

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

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.

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic Truncal Vagotomy

Procedure

Primary outcomes

  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 outcomes

  1. adverse events

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • EndoVx, Inc.
  • University of California, San Francisco

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2008
First posted
Feb 1, 2006
Registry last updated
Feb 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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