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Improving Metabolic Health in Patients With Diastolic Dysfunction

NCT03448185 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-01-05

Study results available
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Summary

The purpose of this study is to determine whether 1 year of supervised exercise training in obese individuals at high risk for developing HF, incorporating high intensity interval training (HIIT) two to three times per week in conjunction with daily oral administration of omega-3 poly-unsaturated fatty acids will lead to reduction in visceral adiposity, regression of myocardial triglyceride levels and improvements in cardiac diastolic and vascular function.

Conditions

  • Obesity
  • Heart Failure, Diastolic
  • Metabolic Syndrome

Interventions

BEHAVIORAL

High intensity exercise

Subjects will be randomized to the exercise groups will undergo 1 year aerobic exercise training comprised of high intensity exercise sessions 2-3 days per week. Sessions will be supervised remotely via heart rate monitors.

DIETARY_SUPPLEMENT

Omega-3 fish oil

Subjects randomized to omega-3 fatty acids will take 2 grams total of omega-3 per day for 1 year.

BEHAVIORAL

Yoga

Subjects randomized to yoga will undergo yoga training as a control to those randomized to high intensity aerobic exercise.

DIETARY_SUPPLEMENT

olive oil capsules

Subjects randomized to receive olive oil placebo will take 1 gram total of olive oil capsule per day.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Benjamin D Levine, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-01
Primary Completion
2019-07-01
Completion
2019-07-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03448185 on ClinicalTrials.gov