Nutritional Therapy for Diabetic Cardiomyopathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Linda Peterson, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01373814
First received: June 13, 2011
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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


Condition
T2DM (Type 2 Diabetes Mellitus)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Nutritional Therapy for Diabetic Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • myocardial steatosis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    myocardial fat deposition as measured using MR spectroscopy


Secondary Outcome Measures:
  • liver steatosis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    liver fat content as measured using MR spectroscopy


Biospecimen Retention:   Samples With DNA

blood samples


Estimated Enrollment: 20
Study Start Date: September 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with known T2DM and who are not taking exogenous insulin.

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%) because systolic dysfunction affects diastolic function.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373814

Contacts
Contact: Deborah Delano, RN 314-747-3876 delanod@mir.wustl.edu
Contact: Marsha Farmer, MS 314-747-3357 mfarmer@dom.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Deborah Delano, RN    314-747-3876    delanod@mir.wustl.edu   
Contact: Marsha Farmer, MS    314-747-3357    mfarmer@dom.wustl.edu   
Principal Investigator: Linda R Peterson, MD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Linda R Peterson, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Linda Peterson, Doctor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01373814     History of Changes
Other Study ID Numbers: 10-1163
Study First Received: June 13, 2011
Last Updated: February 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Cardiomyopathies
Diabetic Cardiomyopathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on September 18, 2014