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Nutritional Therapy for Diabetic Cardiomyopathy

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01373814
First Posted: June 15, 2011
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
The goal of this study is to determine if nutritional therapy can effectively treat/prevent T2DM and its consequent cardiomyopathy.

Condition
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 ]
    cardiac function as measured by echocardiography incl. tissue Doppler


Secondary Outcome Measures:
  • liver steatosis [ Time Frame: 2 weeks ]
    liver fat content as measured using MR spectroscopy

  • myocardial steatosis [ Time Frame: 2 weeks ]
    fat in heart muscle as measured using MR spectroscopy

  • lipidomics [ Time Frame: 2 weeks ]
    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 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with known T2DM and who are not taking exogenous insulin.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01373814


Locations
United States, Missouri
Washington University School of Medicine
St. 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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01373814     History of Changes
Other Study ID Numbers: 10-1163
First Submitted: June 13, 2011
First Posted: June 15, 2011
Last Update Posted: March 30, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiomyopathies
Diabetic Cardiomyopathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Diabetes Complications