Clinical trial NCT01273311: CARDIA Brain MRI Substudy
Official title: Contribution of Diabetes and Its Causes to Signs of Brain Aging in a Young-to-Middle Age Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Aging
Obesity
Diabetes
Keywords: Brain Aging
Diabetes
Aging
Obesity
CARDIA
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2011-01-10
Enrollment: 719
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Background:

- The Coronary Artery Risk Development in Young Adults (CARDIA) study is an investigation of cardiovascular risk factors among African-American and white young adults between 18 and 30 years of age, first recruited in 1985 86 from Birmingham, AL; Chicago, IL; Minneapolis, MN; and Oakland, CA. The study has examined a wide variety of risk factors, including insulin resistance, obesity, and diabetes. Based on 20 years of followup, the data provide evidence of an increase in the prevalence of many cardiovascular risk factors, as well as other factors that may lead to brain disease. To further evaluate these changes, the CARDIA Year 25 Exam will include a brain imaging component to study brain structure and function in a subset of CARDIA participants.

Objectives:

- To conduct brain magnetic resonance imaging as part of a 25-year followup study on participants in the original CARDIA study of heart disease risk factors in young adults.

Eligibility:

- Existing CARDIA study participants in the Minneapolis, MN, and Oakland, CA regions.

Design:

* Participants will be screened with a full medical history and physical examination. - Participants will have an MRI scan at the 25-year followup examination for the CARDIA study.
* No additional testing or treatment will be required for this protocol.

Detailed description: The Coronary Artery Risk Development in Young Adults (CARDIA) Study is a prospective, epidemiologic investigation of the determinants and evolution of cardiovascular risk factors among 5,115 African American and white young to middle age adults 18-30 years of age at baseline in 1985-86. Participants were recruited from the populations of four geographic locations (Birmingham, AL; Chicago, IL; Minneapolis, MN; and Oakland, CA). The study population was approximately balanced according to sex (54% women), ethnicity (52% African American), and education (40% with less than equal to 12 years of education) at each center (Friedman). After the 1984 baseline, additional examinations were undertaken at years 2 (1987-88), 5 (1990-91), 7 (1992-93), 10 (1995-96), 15 (2000-01) and 20 (2005-06). To date, 72% of the total baseline cohort is still active in the study.

Based on 20 years of follow-up, the longitudinal data on this cohort provide clear evidence of an increase in the prevalence of many cardiovascular risk factors, including obesity and diabetes. Therefore, the study presents an ideal and unique opportunity to study change in cardiovascular risk factors beginning at an age we hypothesize may be critical in determining future trajectories of brain disease. Furthermore, the trends in CV-RF reflect general trends in the US population. Thus, CARDIA participants are ideal to study now because the cohort reflects the characteristics of the next generation of older persons.

This is an ancillary study of MRI-evident neurodegenerative and vascular brain changes in a subset of 719 CARDIA participants who participate in the Year 25 Exam. Specifically, we will study the relations of timing length of exposure and levels of cardiovascular risk factors to presence of sub-clinical brain lesions and cognitive impairments. Participants were recruited from the CARDIA field sites at Birmingham, AL (PI: Cora E. Lewis, MD, MSPH- University of Lalbama, Nirmingham), Minneapolis, MN (PI: Pamela Schreiner, PhD, MS- University of Minnesota) and Oakland, CA (PI: Steve Sidney, MD, mPH- Kaiser Permanente).

Eligibility criteria: * INCLUSION CRITERIA:

A qualified participant from the CARDIA trial that does not have any of the below MRI contraindications.

EXCLUSION CRITERIA:

Participants with a known contraindication to an MRI examination will be excluded from the study (severe claustrophobia, pacemaker, defibrillator, neuro-stimulator, ferro-magnetic aneurysm clip or an unknown, 3T MR incompatible metal implant of any kind or any foreign metal objects in the body such as bullets, shrapnel, metal slivers, etc).

Any female participant of childbearing age who has not tested negative on a pregnancy test prior to the scheduled MRI exam will also be excluded from participation in the Brain MRI Substudy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: National Institute of Aging, Clinical Research Unit
state: Maryland
Study officials:
affiliation: National Institute on Aging (NIA)
name: Lenore J Launer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA. 2002 Oct 9;288(14):1723-7. doi: 10.1001/jama.288.14.1723.
citation: Friedman GD, Cutter GR, Donahue RP, Hughes GH, Hulley SB, Jacobs DR Jr, Liu K, Savage PJ. CARDIA: study design, recruitment, and some characteristics of the examined subjects. J Clin Epidemiol. 1988;41(11):1105-16. doi: 10.1016/0895-4356(88)90080-7.
citation: Mainous AG 3rd, Baker R, Koopman RJ, Saxena S, Diaz VA, Everett CJ, Majeed A. Impact of the population at risk of diabetes on projections of diabetes burden in the United States: an epidemic on the way. Diabetologia. 2007 May;50(5):934-40. doi: 10.1007/s00125-006-0528-5. Epub 2006 Nov 21.