Obesity, Type II Diabetes Mellitus
Conditions
Brief summary
This study is an investigation of the metabolomics of RYGB with gastrostomy.
Detailed description
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.
Interventions
PROCEDUREGastric Band
Places a band over the upper portion of the stomach.
PROCEDUREGastric Sleeve
Stapling stomach vertically to reduce size of stomach and removal of larger curve portion of the stomach
PROCEDUREGastrostomy Tube
Tube is inserted into the stomach that delivers nutrition directly into the stomach.
Sponsors
Johnson & Johnson
East Carolina University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Female * 18-60 years of age * BMI of 35-65 * Willing to comply with study requirements and long term follow-up * Capable of understanding the requirements and consequences of surgery and the study * Is scheduled to have bariatric surgery performed * Has a negative pregnancy test
Exclusion criteria
* Repeat gastric bypass procedure * Patients who are unable to hold their insulin coverage for 48 hours prior to research visits * Patients taking TZDs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolics of RYGB with Gastrostomy - Insulin | 03/25/2009-10/12/2012 | The patient will be weighed after voiding. The weight will then be used to determine the amount of insulin to be administered during the minimal model. The following formulas will be used to calculate the insulin dosages: REGULAR INSULIN: body mass (kg) X 0.025 U |
| Metabolics of RYGB with Gastrostomy - Glucose | 03/25/2009-10/12/2012 | The patient will be weighed after voiding. The weight will then be used to determine the amount of glucose to be administered during the minimal model. The following formulas will be used to calculate the glucose dosages: GLUCOSE: mls of 50% solution of glucose= body mass (kg) X 0.3g X 2 |
Countries
United States
Outcome results
None listed