Glucose Metabolism Disorders (Including Diabetes Mellitus)NCT04201600
Glucose Variability and Cognition in Prediabetes
An observational study of Glucose Metabolism Disorders (Including Diabetes Mellitus) and Cognitive Decline, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This study examines the association of variability in glucose values over a 10-day period with cognitive function and AD risk markers among individuals with prediabetes, aged 50 or older. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorders (Including Diabetes Mellitus), Cognitive Decline, PreDiabetes
- What is being tested?
- Continuous Glucose Monitoring System (CGMS)
- Type of treatment
- Medical device
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 16 Sep 2026
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 50 years and older with prediabetes of any duration
Who may be able to join
- Aged 50 years and older
- At least 8th grade education
Who cannot join
- Diagnosed type 1 or type 2 diabetes
- Current use of mediation for diabetes (oral hypoglycemic agents, insulin), or with diabetic properties (e.g., steroids)
- Chronic disorders (cardiovascular disease, peripheral vascular disease, stroke, transient ischemic attack, chronic kidney disease, past year cancer)
- Neurological disorders (e.g., Parkinson's, epilepsy, multiple sclerosis)
- History of dementia or suspected dementia
- Known HIV
- Serious mental illness, psychosis, or use of psychotropic medication
- Heavy alcohol use
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Geriatric Research Education and Clinical Center (GRECC)
Baltimore, Maryland, 21201
About this study
Official title: Relations of Glucose Variability With Cognitive Function and AD Risk Markers Among Older Adults at Risk for Diabetes
This study examines the association of variability in glucose values over a 10-day period with cognitive function and AD risk markers among individuals with prediabetes, aged 50 or older.
Read the detailed description
Type 2 diabetes (T2DM) is now widely considered a major public health epidemic. T2DM is highly prevalent worldwide, is among the leading causes of death, and is an independent risk factor for dementia and less severe forms of cognitive dysfunction. The investigators are utilizing novel technology to understand the role of variability in glucose on neurocognition and Alzheimer's Disease (AD) risk among middle-aged and older adults at risk for diabetes. The central hypothesis is that even before diabetes onset, variability in glucose will be associated with worse cognitive function and higher AD risk. Participants will be asked to wear a glucose monitoring device over a 10-day period in their home environment. Assessment of neurocognitive function and AD risk biomarkers, in addition to sociodemographic factors, health habits and mood will also occur over two study visits.
- Conditions
- Glucose Metabolism Disorders (Including Diabetes Mellitus), Cognitive Decline, PreDiabetes, Aging, Alzheimer's Disease
- Being tested
- Continuous Glucose Monitoring System (CGMS)
- Keywords
- Glucose Variability, Continuous Glucose Monitoring System (CGMS), Prediabetes, Aging, Alzheimer's disease risk, Neurocognitive Function
- Medical subject headings
- Glucose Metabolism Disorders, Cognitive Dysfunction, Prediabetic State, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring System (CGMS)Device
Continuous Glucose Monitoring System (CGMS)- minimally invasive sensors that measure glucose concentrations at 5-min intervals over several days.
| Study group | Role | What they receive |
|---|---|---|
| Middle-aged and Older adults with Prediabetes | Middle-aged and Older adults with Prediabetes Receives: Device: Continuous Glucose Monitoring System (CGMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aggregate Executive Functioning Score
Scores on the following standard neurocognitive tests will be z-transformed based on their respective means and standard deviations and combined into one aggregate total score such that higher values mean better executive functioning:
Trails Making A and B, The Stroop-Color Word Test, Digit Span subscale of the Wechsler Adult Intelligence Scale - Revised (WAIS-IV), Digit Symbol Substitution Test (DSST)
Measured: Day 1
Aggregate Memory Score
Scores on the following standard neurocognitive tests will be z-transformed based on their respective means and standard deviations and combined into one aggregate total score such that higher values mean better memory ability:
California Verbal Learning Test, Benton Visual Retention Test
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 posted17 Dec 2019
- Study start1 Mar 2022
- Primary completion16 Sep 2026
- Study completion16 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism Disorders (Including Diabetes Mellitus)Studies of the same condition, open and under way.
- 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Baltimore VA Medical Center, University of Maryland, Baltimore County, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Leslie Katzel, University of Maryland, Baltimore
- Investigators
- Tasneem Khambaty, PhD, Principal investigator, University of Maryland, Baltimore County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201600
- Sponsor's protocol ID
- HP-00087044
- Other IDs
- R21AG077647
- Status last verified
- Oct 2026
- First submitted
- 5 Dec 2019
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data underlying published results, together with a data dictionary, will be made available following publication of the primary and secondary outcome analyses. Sharing is limited to variables permitted under the IRB-approved informed consent. Biospecimens will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relations of Glucose Variability With Cognitive Function and AD Risk Markers Among Older Adults at Risk for Diabetes
- ClinicalTrials.gov ID
- NCT04201600
- Acronym / sponsor ID
- HP-00087044
- Conditions
- Glucose Metabolism Disorders (Including Diabetes Mellitus), Cognitive Decline, PreDiabetes, Aging, Alzheimer's Disease
- Keywords
- Glucose Variability, Continuous Glucose Monitoring System (CGMS), Prediabetes, Aging, Alzheimer's disease risk, Neurocognitive Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Baltimore VA Medical Center, University of Maryland, Baltimore County, National Institute on Aging (NIA)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 16 Sep 2026 (actual)
- Study completion
- 16 Sep 2026 (actual)
- First posted
- 17 Dec 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.
This study examines the association of variability in glucose values over a 10-day period with cognitive function and AD risk markers among individuals with prediabetes, aged 50 or older.
Detailed description
Type 2 diabetes (T2DM) is now widely considered a major public health epidemic. T2DM is highly prevalent worldwide, is among the leading causes of death, and is an independent risk factor for dementia and less severe forms of cognitive dysfunction. The investigators are utilizing novel technology to understand the role of variability in glucose on neurocognition and Alzheimer's Disease (AD) risk among middle-aged and older adults at risk for diabetes. The central hypothesis is that even before diabetes onset, variability in glucose will be associated with worse cognitive function and higher AD risk. Participants will be asked to wear a glucose monitoring device over a 10-day period in their home environment. Assessment of neurocognitive function and AD risk biomarkers, in addition to sociodemographic factors, health habits and mood will also occur over two study visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Middle-aged and Older adults with Prediabetes | – | Device: Continuous Glucose Monitoring System (CGMS)Middle-aged and Older adults with Prediabetes |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 50 years and older with prediabetes of any duration
Key inclusion criteria (2 listed)
- Aged 50 years and older
- At least 8th grade education
Key exclusion criteria (8 listed)
- Diagnosed type 1 or type 2 diabetes
- Current use of mediation for diabetes (oral hypoglycemic agents, insulin), or with diabetic properties (e.g., steroids)
- Chronic disorders (cardiovascular disease, peripheral vascular disease, stroke, transient ischemic attack, chronic kidney disease, past year cancer)
- Neurological disorders (e.g., Parkinson's, epilepsy, multiple sclerosis)
- History of dementia or suspected dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose Monitoring System (CGMS)Continuous Glucose Monitoring System (CGMS)- minimally invasive sensors that measure glucose concentrations at 5-min intervals over several days. | Device | Middle-aged and Older adults with Prediabetes |
Primary outcome
Aggregate Executive Functioning Score
Time frame: Day 1
Scores on the following standard neurocognitive tests will be z-transformed based on their respective means and standard deviations and combined into one aggregate total score such that higher values mean better executive functioning: Trails Making A and B, The Stroop-Color Word Test, Digit Span subscale of the Wechsler Adult Intelligence Scale - Revised (WAIS-IV), Digit Symbol Substitution Test (DSST)
Aggregate Memory Score
Time frame: Day 1
Scores on the following standard neurocognitive tests will be z-transformed based on their respective means and standard deviations and combined into one aggregate total score such that higher values mean better memory ability: California Verbal Learning Test, Benton Visual Retention Test
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 15 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying published results, together with a data dictionary, will be made available following publication of the primary and secondary outcome analyses. Sharing is limited to variables permitted under the IRB-approved informed consent. Biospecimens will not be shared.
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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.
Tasneem Khambaty, PhD principal investigator
University of Maryland, Baltimore County
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 Glucose Metabolism Disorders (Including Diabetes Mellitus) and Cognitive Decline, run by University of Maryland, Baltimore 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 2 inclusion and 8 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 15 Oct 2026. 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?
Aggregate Executive Functioning Score (time frame: Day 1). The study lists 2 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 15 Oct 2026.