Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00686972
First received: May 27, 2008
Last updated: March 25, 2010
Last verified: March 2010

May 27, 2008
March 25, 2010
May 2007
October 2010   (final data collection date for primary outcome measure)
Insulin secretion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00686972 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
May 2012
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.
Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00686972
NA_00004876
No
Dariush Elahi, PhD, Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Dariush Elahi, PhD Johns Hopkins University
Johns Hopkins University
March 2010

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