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Nutritional Therapy for Diabetic Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT01373814
Recruitment Status : Enrolling by invitation
First Posted : June 15, 2011
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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
T2DM (Type 2 Diabetes Mellitus)

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Nutritional Therapy for Diabetic Cardiomyopathy
Study Start Date : September 2010
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. cardiac function [ Time Frame: 2 weeks ]
    cardiac function as measured by echocardiography incl. tissue Doppler


Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
blood samples


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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.

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

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 Posted: June 15, 2011    Key Record Dates
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