Exercise, Heart Failure, and Type 2 Diabetes

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02122835
• Other study ID #: Pro00032063
• Status: Withdrawn
• Phase: N/A
• Start date: February 2012

Study information

• Verified date: May 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heart Failure
• Type 2 Diabetes

Intervention

Behavioral:
• aerobic exercise training
12 weeks of supervised aerobic exercise training

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	exercise capacity	measured as peak oxygen consumption as well as treadmill time to exhaustion, also known as cardiopulmonary fitness	baseline, 12 weeks
Secondary	flow-mediated dilation	brachial artery flow-mediated dilation	baseline, 12 weeks
Secondary	nitrite flux during exercise	changes in plasma nitrite during exercise	baseline, 12 weeks