Metabolomics of Roux-en-Y Gastric Bypass (RYGB) With Gastrostomy
NCT ID: NCT00887302
Last Updated: 2023-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
13 participants
OBSERVATIONAL
2009-03-25
2012-10-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intestinal Remodeling And Reprogramming of Glucose Metabolism Following Laparoscopic Roux-en-Y Gastric Bypass
NCT02288351
The Effect of Roux-en-Y Gastric Bypass on Mitochondrial Function in Type 2 Diabetes
NCT01468116
Roux-en-Y-Gastric Bypass vs. Lifestyle Modification and Medical Therapy in the Treatment of Type 2 Diabetes
NCT01231308
Changes in Glucose Metabolism After Roux-en-Y Gastric Bypass
NCT01993511
Weight Loss-Independent Metabolic Effects of Roux-En-Y Gastric Bypass in Diabetes
NCT02207777
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Restricted food intake without rerouting food flow cohort
Obese non-diabetic patients and diabetic patients undergoing gastric band surgery will be studied before they have surgery, 1 week after the band is adjusted to restrict food intake and again after they have lost the weight equal to that which gastric bypass patients loose 3 months after surgery (to match data we already have in the current study). All patients will be studied with an intravenous glucose tolerance test to measure insulin sensitivity and IV glucose-induced insulin secretion and a meal challenge to measure the secretion of metabolites and peptides.
Gastric Band
Places a band over the upper portion of the stomach.
Response to meal when a portion of the stomach is excluded from food flow cohort
Obese-diabetic patient undergoing gastric sleeve surgery will be studied before they have surgery, 1 week after surgery and again 3-6 months after surgery (to match data we already have in the current study). The patient will be studied with an intravenous glucose tolerance test to measure insulin sensitivity and insulin secretion and a meal challenge to measure the secretion of metabolites and peptides.
Gastric Sleeve
Stapling stomach vertically to reduce size of stomach and removal of larger curve portion of the stomach
Response to meal when a portion of the GI tract is excluded from food flow cohort
In approximately 6 patients/year our surgeons have to insert a gastrostomy tube into the bypassed stomach of gastric bypass patients. This provides a unique opportunity to see the changes in metabolites and peptides in blood in response to a meal delivered to the bypassed stomach, duodenum and proximal jejunum. Since we can not anticipate which patients will require this procedure, we cannot do tests before surgery, but we will do four tests post-operatively: (1) an IV glucose tolerance test, (2) an oral meal challenge (with Hi-cal), and (3) a meal challenge (identical to that given orally/Hi-Cal) delivered through the gastrostomy tube.
Gastrostomy subjects will also have a 4) test, a 75 gram dextrose meal challenge.
Gastrostomy Tube
Tube is inserted into the stomach that delivers nutrition directly into the stomach.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gastric Band
Places a band over the upper portion of the stomach.
Gastric Sleeve
Stapling stomach vertically to reduce size of stomach and removal of larger curve portion of the stomach
Gastrostomy Tube
Tube is inserted into the stomach that delivers nutrition directly into the stomach.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Patients who are unable to hold their insulin coverage for 48 hours prior to research visits
* Patients taking TZDs
18 Years
60 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Johnson & Johnson
INDUSTRY
East Carolina University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Walter Pories, MD
Role: PRINCIPAL_INVESTIGATOR
East Carolina University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
East Carolina University Brody School of Medicine
Greenville, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
J&J Ethicon
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.