Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01373814
NCT01373814CompletedNot Applicable

Nutritional Therapy for Diabetic Cardiomyopathy

Washington University School of Medicine1 site in 1 country22 target enrollmentStarted: September 3, 2010Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
1
Primary Endpoint
cardiac function
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
35 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

cardiac function

Time Frame: 2 weeks

cardiac function as measured by echocardiography incl. tissue Doppler

Secondary Outcomes

  • liver steatosis(2 weeks)
  • myocardial steatosis(2 weeks)
  • lipidomics(2 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Dietary Intervention in Type-2 Diabetes and Pre-DiabetesPre-diabetesMetabolic SyndromeDiabetes Mellitus, Type 2
NCT02519309Virta Health465
Completed
Not Applicable
Prevention of Type 2 Diabetes Mellitus by Changes in DietPrediabetes
NCT02250066Ilam University of Medical Sciences322
Completed
Not Applicable
A Nutritional Intervention for Diabetic NeuropathyDiabetic Neuropathy
NCT01690962Physicians Committee for Responsible Medicine15
Completed
Not Applicable
A Nutritional Intervention for Diabetic Neuropathy (WCCR-DN2)Diabetic Neuropathy
NCT01953757Physicians Committee for Responsible Medicine20
Completed
Not Applicable
The Effects of Nutritional Intervention in Participants With Eating Disorders.Eating DisordersBinge-Eating DisorderBinge Eating Disorder Associated With ObesityEating BehaviorEating Disorder
NCT06230107Sao Jose do Rio Preto Medical School82