View Clinical Trial (Medical Research Study)
Nutritional Therapy for Diabetic Cardiomyopathy
| City: |
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St. Louis |
| State: |
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Missouri |
| Zip Code: |
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63110 |
| Conditions: |
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T2DM (Type 2 Diabetes Mellitus) |
| Purpose: |
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The goal of this study is to determine if nutritional therapy can effectively treat/prevent
T2DM and its consequent cardiomyopathy.
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| Study Summary: |
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| Criteria: |
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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%) because systolic dysfunction affects diastolic function.
- 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.
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| NCT ID: |
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NCT01373814 |
| Primary Contact: |
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Principal Investigator
Linda R Peterson, MD
Washington University School of Medicine
Deborah Delano, RN
Phone: 314-747-3876
Email: delanod@mir.wustl.edu
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| Backup Contact: |
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Email: kruppk@mir.wustl.edu
Kitty Krupp, RN
Phone: 314-747-0183
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| Location Contact: |
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St. Louis, Missouri 63110
United States
Deborah Delano, RN
Phone: 314-747-3876
Email: delanod@mir.wustl.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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