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

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: Type 2 Diabetes
• Intervention / Treatment: Procedure: bariatric surgery; Behavioral: pre-bariatric weight loss program

Detailed Description

Same as above

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36617
      • University of South Alabama

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: baratric surgery; surgery vs.weight loss program 6 months prior to bariatric surgery	Procedure: bariatric surgery; bariatric surgery for weight loss
Other: 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 Names: weight loss program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Late Outgrowth Endothelial Progenitor Cells	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

• Sponsor: University of South Alabama
• Collaborators: American Society for Metabolic and Bariatric Surgery
• Investigators: Principal Investigator: William O Richards, MD, University of South Alabama, Department of Surgery

Study record dates

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)