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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
David Grant U.S. Air Force Medical Center
ClinicalTrials.gov Identifier:
NCT02040025
First received: January 16, 2014
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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.


Condition
-Type 2 Diabetes Mellitus.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluating the Effects of EECP on Circulation, Blood Glucose Level and Blood Pressure in Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by David Grant U.S. Air Force Medical Center:

Primary Outcome Measures:
  • Change from baseline in TCOM (Transcutaneous oximetry measurement) values [ Time Frame: At baseline & post intervention, expected to be on average 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in hemoglobin A1C laboratory values [ Time Frame: At baseline & post intervention, expected to be on average 30 minutes ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change from baseline in mean resting peripheral blood pressure [ Time Frame: At baseline & post intervention, expected to be on average 10 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  1. Age equal to or greater than 18.
  2. Type 2 diabetes mellitus.
  3. Enrollment in the Travis AFB, CA EECP Clinic.
  4. Department of Defense Beneficiary.

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02040025

Locations
United States, California
David Grant USAF Medical Center
Travis AFB, California, United States, 94535
Sponsors and Collaborators
David Grant U.S. Air Force Medical Center
Investigators
Principal Investigator: Brad Williams, MD David Grant U.S. Air Force Medical Center
  More Information

Publications:
Responsible Party: David Grant U.S. Air Force Medical Center
ClinicalTrials.gov Identifier: NCT02040025     History of Changes
Other Study ID Numbers: FDG20140010H
Study First Received: January 16, 2014
Last Updated: March 26, 2014
Health Authority: United States: Federal Government

Keywords provided by David Grant U.S. Air Force Medical Center:
hypertension
diabetes mellitus
hemoglobin A1C
peripheral vascular resistance
EECP
Blood pressure
angiogenesis
Coronary Artery Disease
Coronary Disease
Heart Diseases
Cardiovascular Diseases

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014