NCT00285220

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2006

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 19, 2009

Status Verified

February 1, 2009

First QC Date

January 31, 2006

Last Update Submit

February 17, 2009

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (12)

  • 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 Outcomes (1)

  • adverse events

Interventions

Laparoscopic Truncal VagotomyPROCEDURE

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California at San Francisco, Dept of Pediatrics

San Francisco, California, 94143, United States

Location

Strong Health Bariatric Center at Highland Hospital

Rochester, New York, 14624, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 31, 2006

First Posted

February 1, 2006

Study Start

September 1, 2005

Study Completion

December 1, 2008

Last Updated

February 19, 2009

Record last verified: 2009-02

Locations

US(2)