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NCT02040025 Clinical Trial

Evaluating the Effects of EECP on Circulation, Blood Glucose Level and Blood Pressure in Type 2 Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:
Evaluating the Effects of EECP on Circulation, Blood Glucose Level and Blood Pressure in Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02040025
Other study ID # FDG20140010H
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date April 2014
Est. completion date October 2016

Study information
Verified date April 2020
Source David Grant U.S. Air Force Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date October 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Age equal to or greater than 18

2. Diagnosis of Type 1 or Type 2 diabetes mellitus

3. Prescribed EECP therapy in the DGMC EECP clinic

4. Medically cleared for EECP therapy

5. TRICARE beneficiary

Exclusion Criteria:

1. DGMC EECP clinic patient withou a diagnosis of Type 1 or Type 2 diabetes mellitus

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States David Grant USAF Medical Center Travis Air Force Base California

Sponsors (1)
Lead Sponsor Collaborator
David Grant U.S. Air Force Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bondesson 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. — View Citation

Braith 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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in TCOM (Transcutaneous oximetry measurement) values At baseline & post intervention, expected to be on average 30 minutes
Secondary Change from baseline in hemoglobin A1C laboratory values At baseline & post intervention, expected to be on average 30 minutes
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