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Sponsored by: |
Johns Hopkins University |
---|---|
Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00686972 |
This study is being conducted to evaluate changes in sugar, metabolism, heart function and changes in body composition as patients lose weight following bariatric surgery. We will compare improvements of the above changes as a function of the four different types of bariatric surgery. We believe the most beneficial and safest procedure will be the Roux-en-Y.
Condition | Intervention | Phase |
---|---|---|
Bariatric Surgery |
Drug: GLP-1 |
Phase II |
Study Type: | Interventional |
Study Design: | Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition |
Estimated Enrollment: | 70 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2012 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
The study will also examine the response of the pancreas (the insulin-producing organ) to a sugar load, as well as to a hormone called GLP-1, which is released from your gut to maximally stimulate your pancreas. The release of this hormone increases when you eat food and it causes the pancreas to release more insulin than does sugar alone. Volunteers will have 22 visits over a two year period. Only people having Roux-en-Y gastric bypass surgery, gastric sleeve surgery, duodenal switch gastric surgery or lap-band/gastric banding surgery may join. Seventy volunteers will be recruited to take part in this study.
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Virginia Andreasik, RN | 410-550-9278 | vfrank@jhmi.edu |
Contact: Melissa Scudder | 410-550-4395 | mscudde1@jhmi.edu |
United States, Maryland | |
Johns Hopkins Bayview Medical Center | Recruiting |
Baltimore, Maryland, United States, 21224 | |
Contact: Virginia Andreasik, RN 410-550-9278 vfrank@jhmi.edu | |
Contact: Melissa Scudder 410-550-4395 mscudde1@jhmi.edu | |
Principal Investigator: Dariush Elahi, PhD | |
Sub-Investigator: Dana Andersen, MD | |
Sub-Investigator: David Bush, MD | |
Sub-Investigator: Nisha Chandra, MD | |
Sub-Investigator: Josephine Egan, MD | |
Sub-Investigator: Bruce R Gibson, MD | |
Sub-Investigator: Andrew Goldberg, MD | |
Sub-Investigator: Edward Lakatta, MD | |
Sub-Investigator: Thomas Magnuson, MD | |
Sub-Investigator: Pamela Ouyang, MD | |
Sub-Investigator: Gregory Prokopowicz, MD, MPH | |
Sub-Investigator: Naresh Punjabi, MD | |
Sub-Investigator: Gabriele Ronnett, MD, PhD | |
Sub-Investigator: John McLenithan, PhD | |
Sub-Investigator: Alice Ryan, PhD | |
Sub-Investigator: Najjar Samer, MD | |
Sub-Investigator: Michael Schweitzer, MD | |
Sub-Investigator: Alan Schuldiner, MD | |
Sub-Investigator: Edward Shapiro, MD | |
Sub-Investigator: Kimberly Steele, MD | |
Sub-Investigator: Varsha Vaidya, MD | |
Sub-Investigator: J. Hunter Young, MD, MHS |
Principal Investigator: | Dariush Elahi, PhD | Johns Hopkins University |
Responsible Party: | Johns Hopkins University ( Dariush Elahi, PhD ) |
Study ID Numbers: | NA_00004876 |
Study First Received: | May 27, 2008 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00686972 |
Health Authority: | United States: Food and Drug Administration |
Bariatric Surgery Glucose Regulation Cardiac Function Body Composition |
Body Weight Signs and Symptoms Glucagon |
Weight Loss Body Weight Changes Glucagon-Like Peptide 1 |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Incretins Hormones Pharmacologic Actions |