Back to resultsExercise, Heart Failure, and Type 2 Diabetes
Primary Purpose
Heart Failure, Type 2 Diabetes
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
aerobic exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring exercise, aerobic exercise
Eligibility Criteria
Inclusion Criteria:
- ≥50 yr of age
- New York Heart Association class II-III CHF and ejection fraction ≤35%
- receiving optimal medical therapy
- sedentary (≤ 30 min/wk structured physical activity).
- Half of volunteers (n=30) will have a diagnosis of type 2 diabetes (CHF+T2D).
Exclusion Criteria:
- smoking
- changes in medication ≤6 wk prior to enrollment
- major cardiovascular event or procedure ≤6 wk prior to enrollment
- foot ulcers
- advanced neuropathy
- co-morbidities or other limitations that may interfere with or prevent volunteers from safely completing the exercise training
- fixed rate pacemaker
- type 1 diabetes mellitus
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
heart failure
heart failure plus type 2 diabetes
Arm Description
aerobic exercise training
aerobic exercise training
Outcomes
Primary Outcome Measures
exercise capacity
measured as peak oxygen consumption as well as treadmill time to exhaustion, also known as cardiopulmonary fitness
Secondary Outcome Measures
flow-mediated dilation
brachial artery flow-mediated dilation
nitrite flux during exercise
changes in plasma nitrite during exercise
Full Information
NCT ID
NCT02122835
First Posted
April 18, 2014
Last Updated
June 13, 2023
Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT02122835
Brief Title
Exercise, Heart Failure, and Type 2 Diabetes
Official Title
Vascular and Metabolic Responses to Exercise Training in Heart Failure With or Without Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding/patient availability
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to understand the differences in how patients with heart failure respond to exercise training compared to patients with heart failure and type 2 diabetes.
Detailed Description
The investigators will measure exercise capacity in patients with heart failure or heart failure plus type 2 diabetes prior to and following a 12-week exercise training program (5d/wk, 30 min/d, 60-75% VO2max) to determine whether improvements in exercise capacity in response to exercise training are mitigated in patients with combined heart failure plus type 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Type 2 Diabetes
Keywords
exercise, aerobic exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
heart failure
Arm Type
Other
Arm Description
aerobic exercise training
Arm Title
heart failure plus type 2 diabetes
Arm Type
Other
Arm Description
aerobic exercise training
Intervention Type
Behavioral
Intervention Name(s)
aerobic exercise training
Intervention Description
12 weeks of supervised aerobic exercise training
Primary Outcome Measure Information:
Title
exercise capacity
Description
measured as peak oxygen consumption as well as treadmill time to exhaustion, also known as cardiopulmonary fitness
Time Frame
baseline, 12 weeks
Secondary Outcome Measure Information:
Title
flow-mediated dilation
Description
brachial artery flow-mediated dilation
Time Frame
baseline, 12 weeks
Title
nitrite flux during exercise
Description
changes in plasma nitrite during exercise
Time Frame
baseline, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥50 yr of age
New York Heart Association class II-III CHF and ejection fraction ≤35%
receiving optimal medical therapy
sedentary (≤ 30 min/wk structured physical activity).
Half of volunteers (n=30) will have a diagnosis of type 2 diabetes (CHF+T2D).
Exclusion Criteria:
smoking
changes in medication ≤6 wk prior to enrollment
major cardiovascular event or procedure ≤6 wk prior to enrollment
foot ulcers
advanced neuropathy
co-morbidities or other limitations that may interfere with or prevent volunteers from safely completing the exercise training
fixed rate pacemaker
type 1 diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Kraus, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Exercise, Heart Failure, and Type 2 Diabetes
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