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NCT Number: NCT04201600

Glucose Variability and Cognition in Prediabetes

This study examines the association of variability in glucose values over a 10-day period with cognitive function and functional status among individuals with prediabetes, aged 50 or older.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baltimore VA Geriatric Research Education and Clinical Center (GRECC)

Baltimore, Maryland, 21201, United States

Location status: Recruiting

Location contact

Tasneem Khambaty, PhD

CONTACT

[email protected]

410-455-2304

About this study

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 functional status 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 lower functional status. Participants will be asked to wear a glucose monitoring device over a 10-day period in their home environment. Assessment of functional status and neurocognitive function, in addition to sociodemographic factors, health habits and mood will also occur over two study visits.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 50 years and older
  • At least 8th grade education

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Aggregate Executive Functioning Score

    Time frame: Day 10

    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)

  2. Aggregate Memory Score

    Time frame: Day 10

    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

  3. Aggregate Language Score

    Time frame: Day 10

    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 language abilities:

    Boston Naming Test, Controlled Oral Word Association Test (COWA)

Secondary outcomes

  1. Aggregate Physical Functioning Score

    Time frame: Day 10

    Scores on the following standard neurocognitive tests will be summed into one aggregate total score such that higher values mean better physical functioning:

    gait speed, short physical performance battery (SPPB), handgrip strength, and four-square step test

  2. Activities of Daily Living (ADL) total score

    Time frame: Day 10

    Responses on this standard measure will be scored according to guidelines to create a total score for functional status

  3. Instrumental Activities of Daily Living (IADL) total score

    Time frame: Day 10

    Responses on this standard measure will be scored according to guidelines to create a total score for functional status

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Splain, BA

CONTACT

[email protected]

Kathleen Simpson

CONTACT

[email protected]

4106057179

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • Baltimore VA Medical Center
  • University of Maryland, Baltimore County

Registry information

Official study title

Relations of Glucose Variability with Cognitive Function and Functional Status Among Older Adults At Risk for Diabetes

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2019
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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