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| Sponsor: | East Carolina University |
|---|---|
| Collaborator: |
Johnson & Johnson |
| Information provided by: | East Carolina University |
| ClinicalTrials.gov Identifier: | NCT00887302 |
Purpose
This study is an investigation of the "metabolics of RYGB with gastrostomy."
| Condition |
|---|
|
Type II Diabetes Mellitus Obesity |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | Johnson and Johnson Ethicon Metabolics of RYGB With Gastrostomy |
| Estimated Enrollment: | 120 |
| Study Start Date: | May 2009 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Gastric Band
|
|
2
Gastric Sleeve
|
|
3
Gastric Bypass with PEG tube
|
The rapid and durable remission of type II diabetes mellitis following the gastric bypass operation challenges the current concepts about the etiology of the disease. The surgery, which excludes food from the stomach, duodenum, and proximal jejunum, is quickly followed by a durable drop in glucose and insulin levels. As a result, 4 out of 5 diabetic, morbidly obese individuals who undergo the operation return to a long-term euglycemia with a prolongation of life and a reduction of health care costs.
The investigators at East Carolina University and those at Johnson and Johnson propose to further complete the profile of the upper gut by extending their observation to three additional human models. The investigators will study patients having the gastric band procedure, the gastric sleeve procedure, and those who have a gastric bypass but have a PEG tube inserted later.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Obese caucasian females between the ages of 18-60 who have had bariatric surgery.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, North Carolina | |
| East Carolina University Brody School of Medicine | Not yet recruiting |
| Greenville, North Carolina, United States, 2783 | |
| Contact: Kelly E Jernigan, BS Biology 252-744-3361 jernigank@ecu.edu | |
| Contact: Rita Bowden, RN 252-744-3361 bowdenr@ecu.edu | |
More Information
| Responsible Party: | Dr. Walter J. Pories, M.D., FACS, Professor of Surgery, Biochemistry, Exercise and Sports Science, East Carolina University |
| ClinicalTrials.gov Identifier: | NCT00887302 History of Changes |
| Other Study ID Numbers: | J&J Ethicon |
| Study First Received: | April 22, 2009 |
| Last Updated: | April 22, 2009 |
| Health Authority: | United States: Institutional Review Board |
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Diabetes Mellitus Diabetes Mellitus, Type 2 Obesity Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms |