Exercise, Heart Failure, and Type 2 Diabetes

Vascular and Metabolic Responses to Exercise Training in Heart Failure With or Without Type 2 Diabetes

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02122835

Enrollment

Registered

2014-04-25

Start date

2012-02-29

Completion date

Unknown

Last updated

2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Type 2 Diabetes

Keywords

exercise, aerobic exercise

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.

Interventions

BEHAVIORALaerobic exercise training

12 weeks of supervised aerobic exercise training

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
flow-mediated dilation	baseline, 12 weeks	brachial artery flow-mediated dilation
nitrite flux during exercise	baseline, 12 weeks	changes in plasma nitrite during exercise

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026