- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01213940
Vascular Endothelium Changes After Bariatric Surgery (Endothelial Progenitor Cells) (EPC)
November 18, 2020 updated by: William Richards, University of South Alabama
Vascular Endothelium Changes After Bariatric Surgery
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Same as above
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Mobile, Alabama, United States, 36617
- University of South Alabama
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: baratric surgery
surgery vs.weight loss program 6 months prior to bariatric surgery
|
bariatric surgery for weight loss
|
Other: pre-bariatric weight loss program
weight loss program prior to bariatric surgery
|
standard 6 month physician directed pre-bariatric weight loss program
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Late Outgrowth Endothelial Progenitor Cells
Time Frame: 24 months
|
Primary outcome is the change in Late outgrowth endothelial progenitor cells 12 months after enrollment to surgery (LRYGB) or to standard medical therapy (SMT).
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: William O Richards, MD, University of South Alabama, Department of Surgery
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
September 30, 2010
First Submitted That Met QC Criteria
September 30, 2010
First Posted (Estimate)
October 4, 2010
Study Record Updates
Last Update Posted (Actual)
December 14, 2020
Last Update Submitted That Met QC Criteria
November 18, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 10-131 (Other Identifier: University of Pittsburgh Cancer Institute)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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