DiabetesNCT03975309
DHS MIND Metabolomics
An observational study of Diabetes, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- How many people
- 417 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to 23 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: European Americans and African Americans with T2D from the general population.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Metabolomics of Neurocognitive Risk for Dementia in Diabetes
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.
Read the 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).
- Conditions
- Diabetes
- Keywords
- Cognition, Dementia, Mild Cognitive Impairment, European American, African American
- Medical subject headings
- Diabetes Mellitus, Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Previous DHS Participants | Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start9 Sep 2019
- Primary completion23 May 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Nicholette D Allred, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975309
- Sponsor's protocol ID
- IRB00057194
- Other IDs
- 1R01AG058921-01A1
- Status last verified
- Dec 2023
- First submitted
- 28 May 2019
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics of Neurocognitive Risk for Dementia in Diabetes
- ClinicalTrials.gov ID
- NCT03975309
- Acronym / sponsor ID
- IRB00057194
- Conditions
- Diabetes
- Keywords
- Cognition, Dementia, Mild Cognitive Impairment, European American, African American
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Previous DHS Participants | – | –Observational |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- European Americans and African Americans with T2D from the general population.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Craft Story Recall (Immediate/Delayed)
Time frame: Day 1
Trail Making Test
Time frame: Day 1
Number Span Test (Forward/Backward)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Diabetes
RecruitingObservational study
Genetics of Type 2 Diabetes in West Africans
Hypertension, Diabetes
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Not yet recruitingPhase 3
A Study Comparing SHR-3167 With Insulin Degludec in Adults With Type 2 Diabetes Currently Treated With Basal Insulin
Diabetes Mellitus, Type 2
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Active, not recruiting
Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes
Type 1 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholette D Allred, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wide Range Achievement Test 4 (WRAT 4) (time frame: up to 25 years prior to Day 1). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.