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Vascular Endothelium Changes After Bariatric Surgery (Endothelial Progenitor Cells) (EPC)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by William Richards, University of South Alabama.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01213940
First Posted: October 4, 2010
Last Update Posted: August 14, 2013
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.
Collaborator:
American Society for Metabolic and Bariatric Surgery
Information provided by (Responsible Party):
William Richards, University of South Alabama
  Purpose
Improvement in cardiovascular mortality is related to changes in pathologic autoantibodies and in the number of circulating functional replicative competent endothelial progenitor cells (EPC's) after bariatric surgery.

Condition Intervention
Type 2 Diabetes Behavioral: pre-bariatric weight loss program Procedure: bariatric surgery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Vascular Endothelium Changes After Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by William Richards, University of South Alabama:

Primary Outcome Measures:
  • Change in plasma autoantibody levels [ Time Frame: 6 months ]
    Primary outcome is the change in plasma autoantibody levels (endothelial barrier function) 6 months after enrollment to surgery (LRYGB) or to standard medical therapy (SMT).


Estimated Enrollment: 70
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
baratric surgery
surgery vs.weight loss program 6 months prior to bariatric surgery
Procedure: bariatric surgery
bariatric surgery for weight loss
pre-bariatric weight loss program
weight loss program prior to bariatric surgery
Behavioral: pre-bariatric weight loss program
standard 6 month physician directed pre-bariatric weight loss program
Other Name: weight loss program

Detailed Description:
Same as above
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 2 Diabetes, Glucose > 200mg/dl, currently be ing treated with oral medications and HGA1c . 6.5, and BMI .35.

Exclusion Criteria:

  • Type 1 Diabetes
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213940


Locations
United States, Alabama
University of South Alabama Recruiting
Mobile, Alabama, United States, 36617
Contact: William O Richards, MD    251-471-7993    brichards@usouthal.edu   
Sponsors and Collaborators
University of South Alabama
American Society for Metabolic and Bariatric Surgery
Investigators
Principal Investigator: William O Richards, MD University of South Alabama, Department of Surgery
  More Information

Responsible Party: William Richards, Professor and Chairman of the Department of Surgery, University of South Alabama
ClinicalTrials.gov Identifier: NCT01213940     History of Changes
Other Study ID Numbers: 10-131
First Submitted: September 30, 2010
First Posted: October 4, 2010
Last Update Posted: August 14, 2013
Last Verified: August 2013