Nutritional Therapy for Diabetic Cardiomyopathy

NCT01373814 | Completed DMC

• 1 other identifier: 10-1163
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

T2DM (Type 2 Diabetes Mellitus)

Outcome Measures

Primary Outcomes (1)

• cardiac function

  cardiac function as measured by echocardiography incl. tissue Doppler

  2 weeks

Secondary Outcomes (3)

• liver steatosis

  2 weeks

• myocardial steatosis

  2 weeks

• lipidomics

  2 weeks

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 26652763 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Linda R Peterson, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: June 15, 2011
• Study Start: September 3, 2010
• Primary Completion: June 17, 2011
• Study Completion: June 17, 2011
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

US (1)