Clinical trial NCT03509441: Early MRI Detection of Myocardial Deterioration as a Preventive, Disease Staging, and Prognostic Biomarker in Insulin Resistance
Official title: Early MRI Detection of Myocardial Deterioration as a Preventive, Disease Staging, and Prognostic Biomarker in Insulin Resistance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiomyopathies
Insulin Resistance
Non-ischemic Cardiomyopathy
Cardiac Fibrosis
Diabetes
Keywords: South Asian
Insulin Resistance
Cardiac Fibrosis
MRI
Diabetes
Cardiomyopathy
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: South Asians between the age of 20 and 60 who have no active coronary heart disease or other non-ischemic cardiomyopathies

Brief summary: The purpose of this study is to evaluate the relationship between insulin resistance (IR) and myocardial tissue abnormalities. The study will focus on a patient population, South Asians, with a high prevalence of IR.

Detailed description: Cardiac fibrosis has been linked to adverse outcomes in non-ischemic cardiomyopathy. Fibrosis is also detectable in diabetic patients, but does not appear to closely track with insulin sensitivity. Hence, fibrosis may be an independent risk factor for adverse outcomes in IR and diabetic patients. As a result, a critical need exists to develop a non-invasive tool to identify and treat the highest-risk patients. Early detection of cardiac fibrosis and other CMR- detectable abnormalities in IR patients may help to 'stage' a patient's disease process and future risk of events, ultimately leading to an adjustment in the aggressiveness of their medical management and long-term monitoring accordingly. This project is aimed at reducing the mortality and morbidity associated with insulin resistance and diabetes, and the investigators believe this project could have a transformative impact on long-term diabetic care and shed new light upon the biology of diffuse cardiac fibrosis in insulin resistance and diabetes and its role in shaping the long-term cardiovascular risk for these patients.

Eligibility criteria: Inclusion Criteria:

- South Asian

Exclusion Criteria:

* Pregnant women
* Patients with prior diagnoses of diabetes
* Patients on insulin therapy
* Patients with known coronary heart disease or other non-ischemic cardiomyopathies

Primary outcomes:
measure: Identifying patients with high fibrosis levels using peripheral blood samples
timeFrame: Blood samples drawn once at baseline visit
measure: Insulin Sensitivity measured by OGTT
timeFrame: OGTT done at baseline/ first visit
measure: Insulin Sensitivity measured by Fasting Lipid Panel
timeFrame: Lipid Panel done at baseline/ first visit
measure: Left ventricular volume
timeFrame: CMR done at baseline visit
measure: Left ventricular mass
timeFrame: CMR done at baseline visit
measure: Ejection fraction %
timeFrame: CMR done at baseline visit
measure: Myocardial tagging for strain analysis
timeFrame: CMR done at baseline visit
measure: Assessing diffuse fibrosis via T1 mapping
timeFrame: CMR done at baseline visit
measure: Assessing level of edema via T2 mapping
timeFrame: CMR done at baseline visit
Secondary outcomes:
measure: Collagen turnover assessment
timeFrame: Blood drawn at baseline visit
measure: Endothelial Function
timeFrame: 15 minute procedure done at baseline visit
measure: Urine test for albumin levels
timeFrame: One urine test done at baseline visit
measure: Urine test for creatinine levels
timeFrame: One urine test done at baseline visit
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Rajesh Dash, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Abha Khandelwal, MD
role: STUDY_DIRECTOR
References: