Nutritional Therapy for Diabetic Cardiomyopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-03

Study Completion Date

2011-06-17

Brief Summary

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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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Detailed Description

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Conditions

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T2DM (Type 2 Diabetes Mellitus)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility 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%)
* 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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No