Nutritional Therapy for Diabetic Cardiomyopathy
This study is currently recruiting participants.
Verified June 2013 by Washington University School of Medicine
Sponsor:
Washington University School of Medicine
Information provided by (Responsible Party):
Linda Peterson, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01373814
First received: June 13, 2011
Last updated: June 11, 2013
Last verified: June 2013
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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:
MedlinePlus related topics:
Cardiomyopathy
Diabetes
Diabetes Complications
Diabetes Type 2
Diabetic Heart Disease
Nutritional Support
U.S. FDA Resources
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: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (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
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: | June 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Cardiomyopathies Cardiomyopathies Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Heart Diseases Cardiovascular Diseases Diabetes Complications |
ClinicalTrials.gov processed this record on June 17, 2013