CardiomyopathiesNCT03509441
Early MRI Detection of Myocardial Deterioration as a Preventive, Disease Staging, and Prognostic Biomarker in Insulin Resistance
An observational study of Cardiomyopathies and Insulin Resistance, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathies, Insulin Resistance, Non-ischemic Cardiomyopathy
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2015to 11 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: South Asians between the age of 20 and 60 who have no active coronary heart disease or other non-ischemic cardiomyopathies
Who may be able to join
- South Asian
Who cannot join
- Pregnant women
- Patients with prior diagnoses of diabetes
- Patients on insulin therapy
- Patients with known coronary heart disease or other non-ischemic cardiomyopathies
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Keywords
- South Asian, Insulin Resistance, Cardiac Fibrosis, MRI, Diabetes, Cardiomyopathy
- Medical subject headings
- Cardiomyopathies, Insulin Resistance, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| South Asians with Insulin Resistance | 125 patients (anticipated) | |
| South Asians without Insulin Resistance | 125 patients (anticipated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying patients with high fibrosis levels using peripheral blood samples
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.
Measured: Blood samples drawn once at baseline visit
Insulin Sensitivity measured by OGTT
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.
Measured: OGTT done at baseline/ first visit
Insulin Sensitivity measured by Fasting Lipid Panel
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.
Measured: Lipid Panel done at baseline/ first visit
Left ventricular volume
Cardiac MRI/ CMR done to noninvasively image heart and determine volume of left ventricle
Measured: CMR done at baseline visit
Left ventricular mass
Cardiac MRI/ CMR done to noninvasively image heart and determine mass of left ventricle
Measured: CMR done at baseline visit
Ejection fraction %
Cardiac MRI/ CMR done to noninvasively image heart and determine ejection fraction
Measured: CMR done at baseline visit
Myocardial tagging for strain analysis
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
Measured: CMR done at baseline visit
Assessing diffuse fibrosis via T1 mapping
A CMR technique called T1 mapping will be performed to calculate level of extracellular volume (ECV), which helps with the quantification of diffuse fibrosis
Measured: CMR done at baseline visit
Assessing level of edema via T2 mapping
A CMR technique called T1 mapping will be performed assess amount of edema in the heart
Measured: CMR done at baseline visit
Secondary outcomes (4)
Collagen turnover assessment
Patients will have blood drawn for serum measurement of propeptides of several procollagens to determine the level of collagen turnover
Measured: Blood drawn at baseline visit
Endothelial Function
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.
Measured: 15 minute procedure done at baseline visit
Urine test for albumin levels
24 Hour urine test for assessment of albumin levels
Measured: One urine test done at baseline visit
Urine test for creatinine levels
24 Hour urine test for assessment of creatinine levels
Measured: One urine test done at baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start15 Jan 2015
- Primary completion11 Sep 2019
- Study completion11 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajesh Dash, MD PHD, Stanford University
- Investigators
- Rajesh Dash, MD, PhD, Principal investigator, Stanford UniversityAbha Khandelwal, MD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509441
- Sponsor's protocol ID
- 31279
- Status last verified
- Mar 2023
- First submitted
- 8 May 2017
- Last updated
- 24 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early MRI Detection of Myocardial Deterioration as a Preventive, Disease Staging, and Prognostic Biomarker in Insulin Resistance
- ClinicalTrials.gov ID
- NCT03509441
- Acronym / sponsor ID
- 31279
- Conditions
- Cardiomyopathies, Insulin Resistance, Non-ischemic Cardiomyopathy, Cardiac Fibrosis, Diabetes
- Keywords
- South Asian, Insulin Resistance, Cardiac Fibrosis, MRI, Diabetes, Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Jan 2015 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 26 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| South Asians with Insulin Resistance | – | –125 patients (anticipated) |
| South Asians without Insulin Resistance | – | –125 patients (anticipated) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- South Asians between the age of 20 and 60 who have no active coronary heart disease or other non-ischemic cardiomyopathies
Key inclusion criteria (1 listed)
- South Asian
Key exclusion criteria (4 listed)
- Pregnant women
- Patients with prior diagnoses of diabetes
- Patients on insulin therapy
- Patients with known coronary heart disease or other non-ischemic cardiomyopathies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Left ventricular volume
Time frame: CMR done at baseline visit
Cardiac MRI/ CMR done to noninvasively image heart and determine volume of left ventricle
Left ventricular mass
Time frame: CMR done at baseline visit
Cardiac MRI/ CMR done to noninvasively image heart and determine mass of left ventricle
Ejection fraction %
Time frame: CMR done at baseline visit
Cardiac MRI/ CMR done to noninvasively image heart and determine ejection fraction
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
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
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
4 secondary outcomes
Collagen turnover assessment
Time frame: Blood drawn at baseline visit
Endothelial Function
Time frame: 15 minute procedure done at baseline visit
Urine test for albumin levels
Time frame: One urine test done at baseline visit
Urine test for creatinine levels
Time frame: One urine test done at baseline visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajesh Dash, MD, PhD principal investigator
Stanford University
Abha Khandelwal, MD study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathies and Insulin Resistance, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying patients with high fibrosis levels using peripheral blood samples (time frame: Blood samples drawn once at baseline visit). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.