Clinical Trials Directory

Trials / Completed

CompletedNCT00887302

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

Johnson and Johnson Ethicon Metabolomics of RYGB With Gastrostomy

Status
Completed
Phase
Study type
Observational
Enrollment
13 (actual)
Sponsor
East Carolina University · Academic / Other
Sex
Female
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREGastric BandPlaces a band over the upper portion of the stomach.
PROCEDUREGastric SleeveStapling stomach vertically to reduce size of stomach and removal of larger curve portion of the stomach
PROCEDUREGastrostomy TubeTube is inserted into the stomach that delivers nutrition directly into the stomach.

Timeline

Start date
2009-03-25
Primary completion
2012-10-12
Completion
2012-10-12
First posted
2009-04-23
Last updated
2023-10-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00887302. Inclusion in this directory is not an endorsement.