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Completed

NCT Number: NCT00887302

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

East Carolina University Brody School of Medicine

Greenville, North Carolina, 27834, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gastric Band

Procedure

Places a band over the upper portion of the stomach.

Gastric Sleeve

Procedure

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

Gastrostomy Tube

Procedure

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

Primary outcomes

  1. Metabolics of RYGB with Gastrostomy - Insulin

    Time frame: 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

  2. Metabolics of RYGB with Gastrostomy - Glucose

    Time frame: 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

Sponsors and collaborators

Lead sponsor

East Carolina University

Other

Collaborators

  • Johnson & Johnson

Registry information

Official study title

Johnson and Johnson Ethicon Metabolomics of RYGB With Gastrostomy

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 23, 2009
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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