Baltimore VA Geriatric Research Education and Clinical Center (GRECC)
Baltimore, Maryland, 21201, United States
Location status: Recruiting
NCT Number: NCT04201600
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.
Interested in participating?
Request Info50 year and older
All sexes
Observational
Baltimore, Maryland, 21201, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous Glucose Monitoring System (CGMS)- minimally invasive sensors that measure glucose concentrations at 5-min intervals over several days.
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)
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
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)
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
Time frame: Day 10
Responses on this standard measure will be scored according to guidelines to create a total score for functional status
Time frame: Day 10
Responses on this standard measure will be scored according to guidelines to create a total score for functional status
Contact information is provided by the study sponsor or research team.
University of Maryland, Baltimore
Other
Relations of Glucose Variability with Cognitive Function and Functional Status Among Older Adults At Risk for Diabetes
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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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