NCT03975309

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
417

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 9, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2023

Completed
Last Updated

December 5, 2023

Status Verified

December 1, 2023

Enrollment Period

3.7 years

First QC Date

May 28, 2019

Last Update Submit

December 1, 2023

Conditions

Diabetes

Keywords

Cognition, Dementia, Mild Cognitive Impairment, European American, African American

Outcome Measures

Primary Outcomes (14)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Day 1

Secondary Outcomes (3)

  • Craft Story Recall (Immediate/Delayed)

    Day 1

  • Trail Making Test

    Day 1

  • Number Span Test (Forward/Backward)

    Day 1

Study Arms (1)

Previous DHS Participants

Observational

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

European Americans and African Americans with T2D from the general population.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, urine, blood

MeSH Terms

Conditions

Diabetes MellitusDementiaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Nicholette D Allred, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2019

First Posted

June 5, 2019

Study Start

September 9, 2019

Primary Completion

May 23, 2023

Study Completion

May 23, 2023

Last Updated

December 5, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)