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OpenTrials
Completed

NCT Number: NCT03509441

Early MRI Detection of Myocardial Deterioration as a Preventive, Disease Staging, and Prognostic Biomarker in Insulin Resistance

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.

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Key information

Conditions

Cardiomyopathies Cardiac Fibrosis Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Hyperinsulinism Insulin Resistance Metabolic Diseases Non-ischemic Cardiomyopathy Nutritional and Metabolic Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Identifying patients with high fibrosis levels using peripheral blood samples

    Time frame: Blood samples drawn once at baseline visit

    The investigators will collect and store peripheral blood samples from every patient, identify those with high and low fibrosis levels using our described protocol, and then select patients with disproportionately high fibrosis levels given their disease burden.

    The investigators can test for the level of fibrosis by generating induced pluripotent stem cell-derived cardiomyocytes (iPSC- CMs) from these collected blood samples. These iPSC-CMs will be tested, in vitro, for drug sensitivity, susceptibility to apoptotic stimuli, and the propensity to produce pro-fibrotic cytokine activation- all factors which will help the investigators determine fibrosis levels.

  2. Insulin Sensitivity measured by OGTT

    Time frame: OGTT done at baseline/ first visit

    An oral glucose tolerance test with insulin measurement (OGTT) will be performed for all the patients. The investigators will draw blood to determine a fasting glucose measurement, and then the patients will be given a 75 g glucose solution to drink. Blood samples will be collected at serial time points (30 minutes, 60 minutes, 120 minutes) after ingestion of this liquid to determine blood glucose and insulin levels. The OGTT will help investigators determine the patient's degree of insulin sensitivity.

  3. Insulin Sensitivity measured by Fasting Lipid Panel

    Time frame: Lipid Panel done at baseline/ first visit

    Baseline fasting lipids will be assessed to calculate a TG/HDL-C ratio, which also correlates with the degree of insulin sensitivity or lack thereof. These results will be correlated to the insulin sensitivity assessment performed by the OGTT.

  4. Left ventricular volume

    Time frame: CMR done at baseline visit

    Cardiac MRI/ CMR done to noninvasively image heart and determine volume of left ventricle

  5. Left ventricular mass

    Time frame: CMR done at baseline visit

    Cardiac MRI/ CMR done to noninvasively image heart and determine mass of left ventricle

  6. Ejection fraction %

    Time frame: CMR done at baseline visit

    Cardiac MRI/ CMR done to noninvasively image heart and determine ejection fraction

  7. Myocardial tagging for strain analysis

    Time frame: CMR done at baseline visit

    Cardiac MRI/ CMR done to noninvasively image heart and assess ventricular function through myocardial tagging. By modulating the magnetization gradient of the MRI prior to acquiring images, any parts of the heart which are not contracting can be identified. These images will be analyzed via strain analysis for such abnormalities in function

  8. Assessing diffuse fibrosis via T1 mapping

    Time frame: CMR done at baseline visit

    A CMR technique called T1 mapping will be performed to calculate level of extracellular volume (ECV), which helps with the quantification of diffuse fibrosis

  9. Assessing level of edema via T2 mapping

    Time frame: CMR done at baseline visit

    A CMR technique called T1 mapping will be performed assess amount of edema in the heart

Secondary outcomes

  1. Collagen turnover assessment

    Time frame: Blood drawn at baseline visit

    Patients will have blood drawn for serum measurement of propeptides of several procollagens to determine the level of collagen turnover

  2. Endothelial Function

    Time frame: 15 minute procedure done at baseline visit

    The investigators will also measure endothelial function using the endoPAT device, which employs noninvasive measurement of finger arterial pulsatile volume changes as a measure of endothelial function. This test takes approximately 15 minutes and is noninvasive.

  3. Urine test for albumin levels

    Time frame: One urine test done at baseline visit

    24 Hour urine test for assessment of albumin levels

  4. Urine test for creatinine levels

    Time frame: One urine test done at baseline visit

    24 Hour urine test for assessment of creatinine levels

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Apr 26, 2018
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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