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

• Sponsor: University of South Alabama (Other)
• Overall Status: Completed
• CT.gov ID: NCT01213940
• Collaborator: American Society for Metabolic and Bariatric Surgery (Other)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 44
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Behavioral: pre-bariatric weight loss program; Procedure: bariatric surgery	N/A

Detailed Description

Same as above

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Vascular Endothelium Changes After Bariatric Surgery
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Late Outgrowth Endothelial Progenitor Cells [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 65 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	University of South Alabama	Mobile	Alabama	United States	36617

Sponsors and Collaborators

• University of South Alabama
• American Society for Metabolic and Bariatric Surgery

Investigators

• Principal Investigator: William O Richards, MD, University of South Alabama, Department of Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: William Richards, Professor and Chairman of the Department of Surgery, University of South Alabama
• ClinicalTrials.gov Identifier: NCT01213940
• Other Study ID Numbers: 10-131
• First Posted: Oct 4, 2010
• Last Update Posted: Dec 14, 2020
• Last Verified: Nov 1, 2020

Study Results

Participant Flow

Arm/Group Title	Baratric Surgery	Pre-bariatric Weight Loss Program
Arm/Group Description	surgery vs.weight loss program 6 months prior to bariatric surgery bariatric surgery: bariatric surgery for weight loss	weight loss program prior to bariatric surgery pre-bariatric weight loss program: standard 6 month physician directed pre-bariatric weight loss program
Period Title: Overall Study
STARTED	14	6
COMPLETED	14	6
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Baratric Surgery	Pre-bariatric Weight Loss Program	Total
Arm/Group Description	surgery vs.weight loss program 6 months prior to bariatric surgery bariatric surgery: bariatric surgery for weight loss	weight loss program prior to bariatric surgery pre-bariatric weight loss program: standard 6 month physician directed pre-bariatric weight loss program	Total of all reporting groups
Overall Participants	14	6	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	14 100%	6 100%	20 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	12 85.7%	4 66.7%	16 80%
Male	2 14.3%	2 33.3%	4 20%
body mass index (kg/m2) [Mean (Full Range) ]
Mean (Full Range) [kg/m2]	46.6	44.1	45.9

Outcome Measures

1. Primary Outcome

Title	Change in Late Outgrowth Endothelial Progenitor Cells
Description	Primary outcome is the change in Late outgrowth endothelial progenitor cells 12 months after enrollment to surgery (LRYGB) or to standard medical therapy (SMT).
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Study population of patients undergoing bariatric surgery compared to a group of morbidly obese patients undergoing medical diet therapy pre bariatric surgery

Arm/Group Title	Bariatric Surgery	Pre-bariatric Weight Loss Program
Arm/Group Description	surgery vs, weight loss program 6 months prior to bariatric surgery	weight loss program prior to bariatric surgery
Measure Participants	14	6
LOEPC colonies/mononuclear cells baseline	0.3 (0.1)	0.2 (0.1)
LOEPC colonies/mononuclear cells 24 months post bariatric surgery	3.1 (.9)	0.1 (0.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bariatric Surgery, Pre-bariatric Weight Loss Program
	Comments	one -way ANOVA was used for the analysis
	Type of Statistical Test	Equivalence
	Comments	95% confidence limit from standard deviation of mean
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

Adverse Events

Time Frame	baseline to 6 months
Adverse Event Reporting Description	no participants were subject to risk of serious adverse events
Arm/Group Title	Baratric Surgery		Pre-bariatric Weight Loss Program
Arm/Group Description	surgery vs.weight loss program 6 months prior to bariatric surgery bariatric surgery: bariatric surgery for weight loss		weight loss program prior to bariatric surgery pre-bariatric weight loss program: standard 6 month physician directed pre-bariatric weight loss program
All Cause Mortality
	Baratric Surgery		Pre-bariatric Weight Loss Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/6 (0%)
Serious Adverse Events
	Baratric Surgery		Pre-bariatric Weight Loss Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Baratric Surgery		Pre-bariatric Weight Loss Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.