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Completed

NCT Number: NCT01373814

Nutritional Therapy for Diabetic Cardiomyopathy

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

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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. cardiac function

    Time frame: 2 weeks

    cardiac function as measured by echocardiography incl. tissue Doppler

Secondary outcomes

  1. liver steatosis

    Time frame: 2 weeks

    liver fat content as measured using MR spectroscopy

  2. myocardial steatosis

    Time frame: 2 weeks

    fat in heart muscle as measured using MR spectroscopy

  3. lipidomics

    Time frame: 2 weeks

    mass spectroscopy measures of plasma lipid species

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 15, 2011
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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