Clinical trial NCT01373814: Nutritional Therapy for Diabetic Cardiomyopathy
Official title: Nutritional Therapy for Diabetic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: T2DM (Type 2 Diabetes Mellitus)
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2011-06-15
Enrollment: 22
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with known T2DM and who are not taking exogenous insulin.

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


Eligibility 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.

Primary outcomes:
measure: cardiac function
timeFrame: 2 weeks
Secondary outcomes:
measure: liver steatosis
timeFrame: 2 weeks
measure: myocardial steatosis
timeFrame: 2 weeks
measure: lipidomics
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Linda R Peterson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Airhart S, Cade WT, Jiang H, Coggan AR, Racette SB, Korenblat K, Spearie CA, Waller S, O'Connor R, Bashir A, Ory DS, Schaffer JE, Novak E, Farmer M, Waggoner AD, Davila-Roman VG, Javidan-Nejad C, Peterson LR. A Diet Rich in Medium-Chain Fatty Acids Improves Systolic Function and Alters the Lipidomic Profile in Patients With Type 2 Diabetes: A Pilot Study. J Clin Endocrinol Metab. 2016 Feb;101(2):504-12. doi: 10.1210/jc.2015-3292. Epub 2015 Dec 10.