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

NCT ID: NCT03509441

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 39 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-15
• Study Completion Date: 2019-11-11

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.

Conditions

Cardiomyopathies; Insulin Resistance; Non-ischemic Cardiomyopathy; Cardiac Fibrosis; Diabetes

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

South Asians with Insulin Resistance

125 patients (anticipated)

No interventions assigned to this group

South Asians without Insulin Resistance

125 patients (anticipated)

No interventions assigned to this group

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Rajesh Dash, MD PHD

Asst Prof-Med Ctr Line

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajesh Dash, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Abha Khandelwal, MD

Role: STUDY_DIRECTOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

31279

Identifier Type: -

Identifier Source: org_study_id