Exercise, Heart Failure, and Type 2 Diabetes

Not Applicable

Withdrawn

• Conditions: Heart Failure; Type 2 Diabetes
• Interventions: Behavioral: aerobic exercise training

• Registration Number: NCT02122835
• Lead Sponsor: Duke University

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2014-04-18
• Study First Submitted QC: 2014-04-23
• Study First Posted: 2014-04-25
• Primary Completion: 2014-09
• Status Verified: 2015-05
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
heart failure plus type 2 diabetes	aerobic exercise training	aerobic exercise training
heart failure	aerobic exercise training	aerobic exercise training

Primary Outcome Measures

Name	Time	Method
exercise capacity	baseline, 12 weeks	measured as peak oxygen consumption as well as treadmill time to exhaustion, also known as cardiopulmonary fitness

Secondary Outcome Measures

Name	Time	Method
flow-mediated dilation	baseline, 12 weeks	brachial artery flow-mediated dilation
nitrite flux during exercise	baseline, 12 weeks	changes in plasma nitrite during exercise

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States