Nutritional Therapy for Diabetic Cardiomyopathy

T2DM (Type 2 Diabetes Mellitus) Clinical Trial

Official title:

Nutritional Therapy for Diabetic Cardiomyopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373814
• Other study ID #: 10-1163
• Status: Completed
• Start date: September 3, 2010
• Est. completion date: June 17, 2011

Study information

• Verified date: January 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this study is to determine if nutritional therapy can effectively treat/prevent T2DM and its consequent cardiomyopathy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 17, 2011
• Est. primary completion date: June 17, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Diabetes Mellitus, Type 2
• Diabetic Cardiomyopathies
• T2DM (Type 2 Diabetes Mellitus)

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac function	cardiac function as measured by echocardiography incl. tissue Doppler	2 weeks
Secondary	liver steatosis	liver fat content as measured using MR spectroscopy	2 weeks
Secondary	myocardial steatosis	fat in heart muscle as measured using MR spectroscopy	2 weeks
Secondary	lipidomics	mass spectroscopy measures of plasma lipid species	2 weeks