Nutritional Therapy for Diabetic Cardiomyopathy | NCT01373814

Studies
Nutritional Therapy for Diabetic Cardiomyopathy

NCT01373814

Sponsor

Washington University School of Medicine

Status

Completed

Last Update Posted

Jan 11, 2024Actual

Enrollment

22Actual

Phase

Not provided

Conditions

T2DM (Type 2 Diabetes Mellitus)

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 3, 2010

Primary Completion Date

Jun 17, 2011Actual

Completion Date

Jun 17, 2011Actual

First Submitted Date

Jun 13, 2011

First Submission Date that Met QC Criteria

Jun 14, 2011

First Posted Date

Jun 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2024

Last Update Posted Date

Jan 11, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

22Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
liver steatosis	liver fat content as measured using MR spectroscopy	2 weeks
myocardial steatosis	fat in heart muscle as measured using MR spectroscopy

Other Outcomes

Not provided

Eligibility Module

Eligibility 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%)
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Name	Affiliation	Role
Linda R Peterson, MD	Washington University School of Medicine	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Washington University School of Medicine		St Louis	Missouri	63110	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26652763	Derived	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases