Viewing Study NCT00887302


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Study NCT ID: NCT00887302
Status: COMPLETED
Last Update Posted: 2023-10-06
First Post: 2009-04-22
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Metabolomics of Roux-en-Y Gastric Bypass (RYGB) With Gastrostomy
Sponsor: East Carolina University
Organization:

Study Overview

Official Title: Johnson and Johnson Ethicon Metabolomics of RYGB With Gastrostomy
Status: COMPLETED
Status Verified Date: 2023-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: