Evaluating the Effects of EECP on Circulation, Blood Glucose Level and Blood Pressure in Type 2 Diabetes Mellitus
1 other identifier
observational
2
1 country
1
Brief Summary
The purpose of this proposed Department of Defense study is to evaluate the effect of Enhanced External Counterpulsation (EECP) on circulation, blood glucose control and blood pressure of type 2 diabetic patients receiving EECP therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2014
Typical duration for all trials
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
First Submitted
Initial submission to the registry
January 16, 2014
CompletedFirst Posted
Study publicly available on registry
January 20, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedApril 7, 2020
April 1, 2020
2 years
January 16, 2014
April 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in TCOM (Transcutaneous oximetry measurement) values
At baseline & post intervention, expected to be on average 30 minutes
Secondary Outcomes (1)
Change from baseline in hemoglobin A1C laboratory values
At baseline & post intervention, expected to be on average 30 minutes
Eligibility Criteria
Department of Defense type 2 diabetic patients enrolled in the Travis AFB, CA EECP clinic.
You may qualify if:
- Age equal to or greater than 18
- Diagnosis of Type 1 or Type 2 diabetes mellitus
- Prescribed EECP therapy in the DGMC EECP clinic
- Medically cleared for EECP therapy
- TRICARE beneficiary
You may not qualify if:
- \. DGMC EECP clinic patient withou a diagnosis of Type 1 or Type 2 diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
David Grant USAF Medical Center
Travis Air Force Base, California, 94535, United States
Related Publications (3)
Martin JS, Beck DT, Aranda JM Jr, Braith RW. Enhanced external counterpulsation improves peripheral artery function and glucose tolerance in subjects with abnormal glucose tolerance. J Appl Physiol (1985). 2012 Mar;112(5):868-76. doi: 10.1152/japplphysiol.01336.2011. Epub 2011 Dec 22.
PMID: 22194326BACKGROUNDBondesson SM, Edvinsson ML, Pettersson T, Edvinsson L. Reduced peripheral vascular reactivity in refractory angina pectoris: Effect of enhanced external counterpulsation. J Geriatr Cardiol. 2011 Dec;8(4):215-23. doi: 10.3724/SP.J.1263.2011.00215.
PMID: 22783308BACKGROUNDBraith RW, Conti CR, Nichols WW, Choi CY, Khuddus MA, Beck DT, Casey DP. Enhanced external counterpulsation improves peripheral artery flow-mediated dilation in patients with chronic angina: a randomized sham-controlled study. Circulation. 2010 Oct 19;122(16):1612-20. doi: 10.1161/CIRCULATIONAHA.109.923482. Epub 2010 Oct 4.
PMID: 20921442BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bradley Williams, MD
David Grant U.S. Air Force Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2014
First Posted
January 20, 2014
Study Start
April 1, 2014
Primary Completion
April 1, 2016
Study Completion
October 1, 2016
Last Updated
April 7, 2020
Record last verified: 2020-04