Nutritional Therapy for Diabetic Cardiomyopathy

January 9, 2024 updated by: Washington University School of Medicine
The goal of this study is to determine if nutritional therapy can effectively treat/prevent T2DM and its consequent cardiomyopathy.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiac function
Time Frame: 2 weeks
cardiac function as measured by echocardiography incl. tissue Doppler
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
liver steatosis
Time Frame: 2 weeks
liver fat content as measured using MR spectroscopy
2 weeks
myocardial steatosis
Time Frame: 2 weeks
fat in heart muscle as measured using MR spectroscopy
2 weeks
lipidomics
Time Frame: 2 weeks
mass spectroscopy measures of plasma lipid species
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Linda R Peterson, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 3, 2010

Primary Completion (Actual)

June 17, 2011

Study Completion (Actual)

June 17, 2011

Study Registration Dates

First Submitted

June 13, 2011

First Submitted That Met QC Criteria

June 14, 2011

First Posted (Estimated)

June 15, 2011

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-1163

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on T2DM (Type 2 Diabetes Mellitus)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe