A Study to Evaluate Magnetic Resonance (MR) to Estimate Liver Fat and Fibrosis Among American Indians with High Rates of Obesity, Insulin Resistance, and Variable Alcohol Use
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 17-002037
Sponsor Protocol Number: 17-002037
About this study
This research study will evaluate magnetic resonance (MR) studies (imaging and elastography) to assess methods to estimate liver fat and fibrosis among American Indians (AI) with high rates of obesity, insulin resistance and variable alcohol (EtOH) use. MR examinations in this study are obtained in the same way as routine images are obtained on MR scanners, using radio waves and magnetic fields.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- The potential participant previously participated in the Strong Heart Study (SHS).
- The potential participant is between 25 and 70 years of age.
- Potential participant is willing and able to complete all procedures and observations specified in the protocol.
- The potential participant has been fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) documents.
Exclusion Criteria:
- The potential participant has any contraindication to MR imaging, such as participants with pacemakers, metallic cardiac valves, magnetic material such as surgical clips, implanted electronic infusion pumps or other conditions that would preclude proximity to a strong magnetic field.
- The potential participant has a history claustrophobia.
- The potential participant is a female who is pregnant.
- The potential participant has alternative causes of liver disease (e.g. viral hepatitis, genetic or autoimmune liver diseases, or diseases that might alter study findings).
- The potential participant exceeds the imaging center’s weight limit.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Alvin Silva, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available