Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| EndoVx, Inc. | INDUSTRY |
| University of California, San Francisco | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Truncal Vagotomy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at San Francisco, Dept of Pediatrics | San Francisco | California | 94143 | United States | ||
Not provided
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Strong Health Bariatric Center at Highland Hospital |
| Rochester |
| New York |
| 14624 |
| United States |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |