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Sponsors and Collaborators: |
East Carolina University Johnson & Johnson |
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Information provided by: | East Carolina University |
ClinicalTrials.gov Identifier: | NCT00887302 |
This study is an investigation of the "metabolics of RYGB with gastrostomy."
Condition |
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Type II Diabetes Mellitus Obesity |
Study Type: | Observational |
Study Design: | 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 |
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1
Gastric Band
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2
Gastric Sleeve
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3
Gastric Bypass with PEG tube
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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.
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:
Responsible Party: | East Carolina University ( Dr. Walter J. Pories, M.D., FACS, Professor of Surgery, Biochemistry, Exercise and Sports Science ) |
Study ID Numbers: | J&J Ethicon |
Study First Received: | April 22, 2009 |
Last Updated: | April 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00887302 History of Changes |
Health Authority: | United States: Institutional Review Board |
Obesity Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Overweight Body Weight Signs and Symptoms |
Diabetes Mellitus, Type 2 Nutrition Disorders Overnutrition Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Body Weight Signs and Symptoms Obesity Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus |
Nutrition Disorders Endocrine System Diseases Overweight Overnutrition Glucose Metabolism Disorders |