Evaluating the Effects of EECP on Circulation, Blood Gluc... | NCT02040025

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

NCT02040025

Sponsor

David Grant U.S. Air Force Medical Center

Status

Terminated

Last Update Posted

Apr 7, 2020Actual

Enrollment

2Actual

Phase

Not provided

Conditions

Diabetes Mellitus

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Apr 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Jan 16, 2014

First Submission Date that Met QC Criteria

Jan 16, 2014

First Posted Date

Jan 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2020

Last Update Posted Date

Apr 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bradley Williams, MD	David Grant U.S. Air Force Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
David Grant USAF Medical Center		Travis Air Force Base	California	94535	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22194326	Background	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.
22783308	Background

ID	Term
D003920	Diabetes Mellitus
D006973	Hypertension
D003324	Coronary Artery Disease
D003327	Coronary Disease
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases