Vascular Endothelium Changes After Bariatric Surgery (Endothelial Progenitor Cells)

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: pre-bariatric weight loss program; Procedure: bariatric surgery

• Registration Number: NCT01213940
• Lead Sponsor: University of South Alabama

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.

Detailed Description

Same as above

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-30
• Study First Submitted QC: 2010-09-30
• Study First Posted: 2010-10-04
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Results First Submitted: 2017-11-27
• Results First Submitted QC: 2020-11-18
• Results First Posted: 2020-12-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pre-bariatric weight loss program	pre-bariatric weight loss program	weight loss program prior to bariatric surgery
baratric surgery	bariatric surgery	surgery vs.weight loss program 6 months prior to bariatric surgery

Primary Outcome Measures

Name	Time	Method
Change in Late Outgrowth Endothelial Progenitor Colonies	24 months	Primary outcome is the change in Late outgrowth endothelial progenitor colonies 12 months after enrollment to surgery (LRYGB) or to standard medical therapy (SMT).

Trial Locations

Locations (1)

University of South Alabama; 🇺🇸 Mobile, Alabama, United States