Nutritional Therapy for Diabetic Cardiomyopathy

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Washington University School of Medicine Identifier:
First received: June 13, 2011
Last updated: May 3, 2016
Last verified: May 2016
The goal of this study is to determine if nutritional therapy can effectively treat/prevent T2DM and its consequent cardiomyopathy.

T2DM (Type 2 Diabetes Mellitus)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Nutritional Therapy for Diabetic Cardiomyopathy

Resource links provided by NLM:

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • cardiac function [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    cardiac function as measured by echocardiography incl. tissue Doppler

Secondary Outcome Measures:
  • liver steatosis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    liver fat content as measured using MR spectroscopy

  • myocardial steatosis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    fat in heart muscle as measured using MR spectroscopy

  • lipidomics [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    mass spectroscopy measures of plasma lipid species

Biospecimen Retention:   Samples With DNA
blood samples

Estimated Enrollment: 20
Study Start Date: September 2010
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with known T2DM and who are not taking exogenous insulin.

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
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Please refer to this study by its identifier: NCT01373814

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Linda R Peterson, MD Washington University School of Medicine
  More Information

Responsible Party: Washington University School of Medicine Identifier: NCT01373814     History of Changes
Other Study ID Numbers: 10-1163 
Study First Received: June 13, 2011
Last Updated: May 3, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetic Cardiomyopathies
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Metabolic Diseases processed this record on May 26, 2016