The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition - Full Text View

Sponsored by:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00686972

Purpose

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

MedlinePlus related topics: Weight Control Weight Loss Surgery

Drug Information available for: Dextrose Glucagon-like peptide 1 Glucagon

U.S. FDA Resources

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

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Insulin secretion [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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)

Intervention Details:

5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female volunteers 21-65 years.
BMI > 40.
Preoperative hematocrit level of at least 34% for women and 38% for men.
Postoperative hematocrit level of at least 34% for women and 36% for men.

Exclusion Criteria:

Volunteers whose hematocrit level does not meet the above criteria.
Pregnant and or lactating females.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686972

Contacts

Contact: Virginia Andreasik, RN	410-550-9278	vfrank@jhmi.edu
Contact: Melissa Scudder	410-550-4395	mscudde1@jhmi.edu

Locations

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

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:

Dariush Elahi, PhD

Johns Hopkins University

More Information

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

Keywords provided by Johns Hopkins University:

Bariatric Surgery
Glucose Regulation
Cardiac Function
Body Composition

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Glucagon

Weight Loss
Body Weight Changes
Glucagon-Like Peptide 1

Additional relevant MeSH terms:

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009