Exercise, Heart Failure, and Type 2 Diabetes

June 13, 2023 updated by: Duke University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: heart failure
aerobic exercise training
Behavioral: aerobic exercise training
12 weeks of supervised aerobic exercise training
Other: heart failure plus type 2 diabetes
aerobic exercise training
Behavioral: aerobic exercise training
12 weeks of supervised aerobic exercise training

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: William Kraus, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

April 18, 2014

First Submitted That Met QC Criteria

April 23, 2014

First Posted (Estimated)

April 25, 2014

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00032063

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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