An observational study in Diabetes, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by Wake Forest University Health Sciences · Observational
The study team will evaluate whether metabolomic signatures of neurocognitive decline trajectories are exacerbated by the presence of type 2 diabetes mellitus (T2D) and whether these signatures contribute in part, to ethnic disparities in cognitive decline between European Americans and African Americans with T2D.
Aim 1. Re-examine the Diabetes Heart Study Memory IN Diabetes (DHS MIND) cohort for progression of neurocognitive decline using an established cognitive battery, literacy testing, and adjudicated physician diagnosis of dementia.Another neurocognitive evaluation will be completed in European-American and African-American DHS MIND participants, providing longitudinal follow-up more than eight years after initial assessment. The cognitive battery will reassess domains of executive function, memory, and global cognition. In addition, a clinical exam will include a literacy evaluation to circumvent the shortcomings of differences in educational attainment among participants. A physician adjudicated assessment of cognitively normal, mild cognitive impairment, or dementia will be obtained. Cognitive evaluations will inform epidemiological analyses regarding cross-sectional and trajectories of cognition decline relative to existing and repeat measures of cardio-metabolic risk factors.
Aim 2. Examine the metabolomic basis of neurocognitive measures in people with T2D. The presence of T2D, cardiovascular disease and reduced kidney function are significant risk factors for development of cognitive impairment. These risk factors are enriched in the DHS and lack early diagnostic tools. Untargeted metabolomic profiling offers the potential to identify relevant biomarkers that could impact the diagnosis, prognosis, and treatment of cognitive decline. This will be accomplished through untargeted metabolomic analysis of European American and African American DHS MIND participants using stored samples from baseline visits acquired more than 10 years prior to the current (repeat) neurocognitive assessment. These data will be used to A) provide information on novel mechanistic insights into cognition and trajectories of cognitive decline, B) develop a risk prediction model using the baseline exam, and C) validate extremes of neurocognitive performance using longitudinal assessments while examining ancestry/ethnic-specific differences.
Aim 3. Comprehensive genetic analysis of DHS participants to examine the genetic architecture of metabolomic signatures associated with the trajectories of neurocognitive decline. Existing genome-wide data will be used to map regions of the human genome that contain loci contributing to measures of neurocognition and metabolomics signatures of change in these variables through longitudinal assessment. Causal effect modeling will validate the association of modifiable exposures, i.e. genetic markers and metabolites on the outcome (i.e. trajectories of neurocognitive decline).
11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 417 is above the median of 234 across 2,254 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.
Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
European Americans and African Americans with T2D from the general population.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Observational
Wide Range Achievement Test 4 (WRAT 4)
Word reading subtest to measure letter and word decoding through word recognition and letter identification. This outcome is a data pull/chart review from a previous study for some of the participants.Score range is 0-70, 70 is the best score possible.
Time frame: up to 25 years prior to Day 1
Wide Range Achievement Test 4 (WRAT 4)
Word reading subtest to measure letter and word decoding through word recognition and letter identification. Score range is 0-70, 70 is the best score possible.
Time frame: Day 1
Rey Auditory Verbal Learning Test (RAVLT)
A word recall list that measures verbal learning and memory. Involves immediate and delayed recall. This outcome is a data pull/chart review from a previous study for some of the participants. Score range is 0-75, 75 is the best possible score.
Time frame: up to 25 years prior to Day 1
Rey Auditory Verbal Learning Test (RAVLT)
A word recall list that measures verbal learning and memory. Involves immediate and delayed recall. Score range is 0-75, 75 is the best possible score.
Time frame: Day 1
Modified Mini-Mental State Exam (3MSE)
Measures general cognitive function. This outcome is a data pull/chart review from a previous study for some of the participants. Score range is 0-100, 100 is the best possible score.
Time frame: up to 25 years prior to Day 1
Modified Mini-Mental State Exam (3MSE)
Measures general cognitive function. Score range is 0-100, 100 is the best possible score.
Time frame: Day 1
Digit Symbol Coding Task (DSC)
DSC is a subtest of the Wechsler Adult Intelligence Scale III or IV. It is used to access visual motor speed. This outcome is a data pull/chart review from a previous study for some of the participants. Score range 0-133, 133 is the best possible score.
Time frame: up to 25 years prior to Day 1
Digit Symbol Coding Task (DSC)
DSC is a subtest of the Wechsler Adult Intelligence Scale III or IV. It is used to access visual motor speed. Score range 0-133, 133 is the best possible score.
Time frame: Day 1
Stroop subtests 1, 2 and 3
Measures executive function by determining interchanging word and color challenges. This outcome is a data pull/chart review from a previous study for some of the participants. Score range 0-420 seconds, the lower time point is the best.
Time frame: up to 25 years prior to Day 1
Stroop subtests 1, 2 and 3
Measures executive function by determining interchanging word and color challenges. Score range 0-420 seconds, the lower time point is the best.
Time frame: Day 1
Category Fluency for Animals
Measures verbal fluency and language aspects of executive function by asking participant to name as many unique items as possible in a category ie. animals. This outcome is a data pull/chart review from a previous study for some of the participants. Score 0-26, the best possible score is 26.
Time frame: up to 25 years prior to Day 1
Category Fluency for Animals
Measures verbal fluency and language aspects of executive function by asking participant to name as many unique items as possible in a category ie. animals. Score 0-26, the best possible score is 26.
Time frame: Day 1
Montreal Cognitive Assessments (MoCA)
Measures general cognitive and executive function, has increased sensitivity for detecting early cognitive impairment.This outcome is a data pull/chart review from a previous study for some of the participants. Score range is 0-30, 30 is the best possible score.
Time frame: up to 25 years prior to Day 1
Montreal Cognitive Assessments (MoCA)
Measures general cognitive and executive function, has increased sensitivity for detecting early cognitive impairment.Score range is 0-30, 30 is the best possible score.
Time frame: Day 1
Craft Story Recall (Immediate/Delayed)
Assesses the ability to retell a story from memory immediately and after a delay of approximately 20 minutes. Score 0-69 (for each portions of the test). The best possible score is 69.
Time frame: Day 1
Trail Making Test
Measures processing speed and executive function. Part A- Score 0-150 sec, Part B Score 0-300 sec, the fastest time is better.
Time frame: Day 1
Number Span Test (Forward/Backward)
Assesses working memory recalling numbers said forwards and backwards in increasing number of digits. Score 0-28, the best score possible is 28.
Time frame: Day 1
Plan to share: No
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Ran from Sep 2019 to primary completion in May 2023, 44 months.
Of 630 non-industry observational studies under Diabetes Mellitus, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 130. This study's 44 months is close to that.
Counting every sponsor, half of 771 studies reached it within 36 months; a quarter within 15 and three quarters within 81.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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