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

April 3, 2020 updated by: David Grant U.S. Air Force Medical Center
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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Travis Air Force Base, California, United States, 94535
        • David Grant USAF Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Department of Defense type 2 diabetic patients enrolled in the Travis AFB, CA EECP clinic.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in TCOM (Transcutaneous oximetry measurement) values
Time Frame: At baseline & post intervention, expected to be on average 30 minutes
At baseline & post intervention, expected to be on average 30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in hemoglobin A1C laboratory values
Time Frame: At baseline & post intervention, expected to be on average 30 minutes
At baseline & post intervention, expected to be on average 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Grant U.S. Air Force Medical Center

Investigators

  • Principal Investigator: Bradley Williams, MD, David Grant U.S. Air Force Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

January 16, 2014

First Submitted That Met QC Criteria

January 16, 2014

First Posted (Estimate)

January 20, 2014

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 3, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDG20140010H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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