Metabolomics of Roux-en-Y Gastric Bypass (RYGB) With Gastrostomy

East Carolina University13 enrolled

Overview

This study is an investigation of the "metabolomics of RYGB with gastrostomy."

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Type II Diabetes Mellitus Obesity

Interventions

Gastric BandPROCEDURE

Places a band over the upper portion of the stomach.

Gastric SleevePROCEDURE

Stapling stomach vertically to reduce size of stomach and removal of larger curve portion of the stomach

Gastrostomy TubePROCEDURE

Tube is inserted into the stomach that delivers nutrition directly into the stomach.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

East Carolina University Brody School of Medicine

Greenville, North Carolina, United States

Outcomes

Primary Outcomes

Metabolics of RYGB with Gastrostomy - Insulin

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

Time frame: 03/25/2009-10/12/2012

Metabolics of RYGB with Gastrostomy - Glucose

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

Time frame: 03/25/2009-10/12/2012

Data from ClinicalTrials.gov

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