Aging, Cognitive Decline, Depression, Functional Status, Glucose Metabolism Disorders (Including Diabetes Mellitus), PreDiabetes
Conditions
Keywords
Glucose Variability, Continuous Glucose Monitoring System (CGMS), Prediabetes, Aging, Physical Functioning, Neurocognition, Cognitive Decline
Brief summary
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.
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 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.
Interventions
Continuous Glucose Monitoring System (CGMS)- minimally invasive sensors that measure glucose concentrations at 5-min intervals over several days.
Sponsors
Baltimore VA Medical Center
University of Maryland, Baltimore County
University of Maryland, Baltimore
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aggregate Executive Functioning Score | 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) |
| Aggregate Memory Score | 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 |
| Aggregate Language Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Aggregate Physical Functioning Score | 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 |
| Activities of Daily Living (ADL) total score | Day 10 | Responses on this standard measure will be scored according to guidelines to create a total score for functional status |
| Instrumental Activities of Daily Living (IADL) total score | Day 10 | Responses on this standard measure will be scored according to guidelines to create a total score for functional status |
Countries
United States
Contacts
Primary ContactKathleen Simpson
Backup ContactAshley Splain, BA
Outcome results
None listed