Nutritional Therapy for Diabetic Cardiomyopathy

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01373814
Collaborator
(none)
20
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113
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Study Details

Study Description

Brief Summary

The goal of this study is to determine if nutritional therapy can effectively treat/prevent T2DM and its consequent cardiomyopathy.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Nutritional Therapy for Diabetic Cardiomyopathy
    Study Start Date :
    Sep 3, 2010
    Actual Primary Completion Date :
    Feb 1, 2020
    Actual Study Completion Date :
    Feb 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. cardiac function [2 weeks]

      cardiac function as measured by echocardiography incl. tissue Doppler

    Secondary Outcome Measures

    1. liver steatosis [2 weeks]

      liver fat content as measured using MR spectroscopy

    2. myocardial steatosis [2 weeks]

      fat in heart muscle as measured using MR spectroscopy

    3. lipidomics [2 weeks]

      mass spectroscopy measures of plasma lipid species

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Subjects must be >30 and <65 years of age, in order to limit the confounding affect of age on our endpoints.

    • Subjects must have an ejection fraction >45% (based on their echocardiogram)

    • Patients with T2DM and nonalcoholic fatty liver disease or steatohepatitis may be included since they have extensive evidence of steatosis.

    Exclusion Criteria:
    • Subjects who have had a myocardial infarction or resting ischemia (by history or as evidenced by hypo/akinesis on the pre-intervention echocardiogram) will be excluded because hypo/akinesis would affect our endpoints of LV mass and diastolic function.

    • Subjects who are unstable, not able to lie flat for the imaging studies, unable to give informed consent, pregnant, lactating, with atrial fibrillation (which would compromise measurement of E'), or current smokers will be excluded.

    • Subjects with other major systemic diseases per their clinical charts, history, physical exam, or significant renal insufficiency will also be excluded, as these other system diseases may affect our study endpoints and subject follow-up.

    • We will exclude patients with significant LV systolic dysfunction (ejection fraction <45%)

    • We will not exclude patients with sleep apnea because it does not detrimentally affect LV diastolic function.

    • Subjects will be excluded a priori if they have any history or evidence of liver disease other than NAFLD, consumed >20 g alcohol per day.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington University School of Medicine Saint Louis Missouri United States 63110

    Sponsors and Collaborators

    • Washington University School of Medicine

    Investigators

    • Principal Investigator: Linda R Peterson, MD, Washington University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT01373814
    Other Study ID Numbers:
    • 10-1163
    First Posted:
    Jun 15, 2011
    Last Update Posted:
    Feb 10, 2021
    Last Verified:
    Feb 1, 2021

    Study Results

    No Results Posted as of Feb 10, 2021