Trial Outcomes & Findings for Vascular Endothelium Changes After Bariatric Surgery (Endothelial Progenitor Cells) (NCT NCT01213940)

NCT ID: NCT01213940

Last Updated: 2024-05-09

Results Overview

Primary outcome is the change in Late outgrowth endothelial progenitor colonies 12 months after enrollment to surgery (LRYGB) or to standard medical therapy (SMT).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2024-05-09

Participant Flow

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vascular Endothelium Changes After Bariatric Surgery (Endothelial Progenitor Cells)

Baseline characteristics by cohort

Measure	Baratric Surgery n=14 Participants surgery vs.weight loss program 6 months prior to bariatric surgery bariatric surgery: bariatric surgery for weight loss	Pre-bariatric Weight Loss Program n=6 Participants weight loss program prior to bariatric surgery pre-bariatric weight loss program: standard 6 month physician directed pre-bariatric weight loss program	Total n=20 Participants Total of all reporting groups
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants
body mass index	46.6 kg/m2 n=5 Participants	44.1 kg/m2 n=7 Participants	45.9 kg/m2 n=5 Participants

PRIMARY outcome

Timeframe: 24 months

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

Primary outcome is the change in Late outgrowth endothelial progenitor colonies 12 months after enrollment to surgery (LRYGB) or to standard medical therapy (SMT).

Outcome measures

Measure	Bariatric Surgery n=14 Participants surgery vs, weight loss program 6 months prior to bariatric surgery	Pre-bariatric Weight Loss Program n=6 Participants weight loss program prior to bariatric surgery
Change in Late Outgrowth Endothelial Progenitor Colonies LOEPC Colonies baseline	0.3 LOEPC colonies Standard Error 0.1	0.2 LOEPC colonies Standard Error 0.1
Change in Late Outgrowth Endothelial Progenitor Colonies LOEPC colonies 24 months post bariatric surgery	3.1 LOEPC colonies Standard Error .9	0.1 LOEPC colonies Standard Error 0.1

Adverse Events

Baratric Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pre-bariatric Weight Loss Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William O. Richards, MD

University of South Alabama, Department of Surgery

Phone: 251-471-7993

Email: brichards@health.southalabama.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place