Nutritional Therapy for Diabetic Cardiomyopathy

Completed

• Conditions: T2DM (Type 2 Diabetes Mellitus)

• Registration Number: NCT01373814
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-09-03
• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-06-14
• Study First Posted: 2011-06-15
• Primary Completion: 2011-06-17
• Study Completion: 2011-06-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cardiac function	2 weeks	cardiac function as measured by echocardiography incl. tissue Doppler

Secondary Outcome Measures

Name	Time	Method
liver steatosis	2 weeks	liver fat content as measured using MR spectroscopy
myocardial steatosis	2 weeks	fat in heart muscle as measured using MR spectroscopy
lipidomics	2 weeks	mass spectroscopy measures of plasma lipid species

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States