Vascular Endothelium Changes After Bariatric Surgery (Endothelial Progenitor Cells)
EPC
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes
Started Sep 2010
Longer than P75 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 30, 2010
CompletedFirst Posted
Study publicly available on registry
October 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
December 14, 2020
CompletedMay 9, 2024
May 1, 2024
3.7 years
September 30, 2010
November 27, 2017
May 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Late Outgrowth Endothelial Progenitor Colonies
Primary outcome is the change in Late outgrowth endothelial progenitor colonies 12 months after enrollment to surgery (LRYGB) or to standard medical therapy (SMT).
24 months
Study Arms (2)
baratric surgery
OTHERsurgery vs.weight loss program 6 months prior to bariatric surgery
pre-bariatric weight loss program
OTHERweight loss program prior to bariatric surgery
Interventions
standard 6 month physician directed pre-bariatric weight loss program
Eligibility Criteria
You may qualify if:
- Type 2 Diabetes, Glucose \> 200mg/dl, currently be ing treated with oral medications and HGA1c . 6.5, and BMI .35.
You may not qualify if:
- Type 1 Diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of South Alabama
Mobile, Alabama, 36617, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- William O. Richards, MD
- Organization
- University of South Alabama, Department of Surgery
Study Officials
- PRINCIPAL INVESTIGATOR
William O Richards, MD
University of South Alabama, Department of Surgery
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chairman of the Department of Surgery
Study Record Dates
First Submitted
September 30, 2010
First Posted
October 4, 2010
Study Start
September 1, 2010
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
May 9, 2024
Results First Posted
December 14, 2020
Record last verified: 2024-05