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DHS MIND Metabolomics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03975309
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : February 2, 2023
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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Brief Summary:
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.

Condition or disease
Diabetes

Detailed Description:

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).

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metabolomics of Neurocognitive Risk for Dementia in Diabetes
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2025
Groups and Cohorts
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Group/Cohort
Previous DHS Participants
Observational


Outcome Measures
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Primary Outcome Measures :
  1. Wide Range Achievement Test 4 (WRAT 4) [ Time Frame: up to 25 years prior to Day 1 ]
    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.

  2. Wide Range Achievement Test 4 (WRAT 4) [ Time Frame: Day 1 ]
    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.

  3. Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: up to 25 years prior to Day 1 ]
    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.

  4. Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: Day 1 ]
    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.

  5. Modified Mini-Mental State Exam (3MSE) [ Time Frame: up to 25 years prior to Day 1 ]
    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.

  6. Modified Mini-Mental State Exam (3MSE) [ Time Frame: Day 1 ]
    Measures general cognitive function. Score range is 0-100, 100 is the best possible score.

  7. Digit Symbol Coding Task (DSC) [ Time Frame: up to 25 years prior to Day 1 ]
    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.

  8. Digit Symbol Coding Task (DSC) [ Time Frame: Day 1 ]
    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.

  9. Stroop subtests 1, 2 and 3 [ Time Frame: up to 25 years prior to Day 1 ]
    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.

  10. Stroop subtests 1, 2 and 3 [ Time Frame: Day 1 ]
    Measures executive function by determining interchanging word and color challenges. Score range 0-420 seconds, the lower time point is the best.

  11. Category Fluency for Animals [ Time Frame: up to 25 years prior to Day 1 ]
    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.

  12. Category Fluency for Animals [ Time Frame: Day 1 ]
    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.

  13. Montreal Cognitive Assessments (MoCA) [ Time Frame: up to 25 years prior to Day 1 ]
    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.

  14. Montreal Cognitive Assessments (MoCA) [ Time Frame: Day 1 ]
    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.


Secondary Outcome Measures :
  1. Craft Story Recall (Immediate/Delayed) [ Time Frame: Day 1 ]
    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.

  2. Trail Making Test [ Time Frame: Day 1 ]
    Measures processing speed and executive function. Part A- Score 0-150 sec, Part B Score 0-300 sec, the fastest time is better.

  3. Number Span Test (Forward/Backward) [ Time Frame: Day 1 ]
    Assesses working memory recalling numbers said forwards and backwards in increasing number of digits. Score 0-28, the best score possible is 28.


Biospecimen Retention:   Samples With DNA
Serum, plasma, urine, blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
European Americans and African Americans with T2D from the general population.
Criteria

Inclusion Criteria:

• At the baseline visit, European American and African American individuals with T2D must have had diabetes diagnosed after the age of 30, 3 years disease duration and lack historical evidence of diabetic ketoacidosis.

Exclusion Criteria:

  • At the baseline visit, participants with pre-existing kidney disease, defined as a serum creatinine concentration >1.5 mg/dl or blood urea nitrogen >35 mg/dl were excluded due to the elevation of serum AGE levels in individuals with kidney disease.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975309


Locations
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United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Pamela Hicks    336-713-7539    panderso@wakehealth.edu   
Contact: Ben Bagwell    3367165777    bbagwell@wakehealth.edu   
Principal Investigator: Nicholette D Allred, PhD         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Nicholette D Allred, PhD Wake Forest University Health Sciences
More Information
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03975309    
Other Study ID Numbers: IRB00057194
1R01AG058921-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: February 2, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Cognition, Dementia, Mild Cognitive Impairment, European American, African American