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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
American Society for Metabolic and Bariatric Surgery
Information provided by (Responsible Party):
William Richards, University of South Alabama Identifier:
First received: September 30, 2010
Last updated: August 12, 2013
Last verified: August 2013
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: 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

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

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
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Please refer to this study by its identifier: NCT01213940

United States, Alabama
University of South Alabama Recruiting
Mobile, Alabama, United States, 36617
Contact: William O Richards, MD    251-471-7993   
Sponsors and Collaborators
University of South Alabama
American Society for Metabolic and Bariatric Surgery
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 Identifier: NCT01213940     History of Changes
Other Study ID Numbers: 10-131
Study First Received: September 30, 2010
Last Updated: August 12, 2013 processed this record on May 25, 2017