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The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition

This study has been terminated.
(PI left JHU)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00686972
First Posted: May 30, 2008
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johns Hopkins University
May 27, 2008
May 30, 2008
May 1, 2017
July 2, 2017
July 2, 2017
May 2007
October 2010   (Final data collection date for primary outcome measure)
Insulin Secretion [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT00686972 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition
The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition
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. The investigators will compare improvements of the above changes as a function of the four different types of bariatric surgery. The investigators believe the most beneficial and safest procedure will be the Roux-en-Y.
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 Glucagon Like Peptide 1 (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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Bariatric Surgery
Drug: GLP-1
5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
Other Name: Glucagon-like Peptide-1
Experimental: GLP-1
5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
Intervention: Drug: GLP-1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
51
October 2010
October 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00686972
NA_00004876
No
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Dariush Elahi, PhD Johns Hopkins University
Johns Hopkins University
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP