Glucose Variability and Cognition in Prediabetes
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Middle-aged and Older adults with Prediabetes Middle-aged and Older adults with Prediabetes |
Device: Continuous Glucose Monitoring System (CGMS)
Continuous Glucose Monitoring System (CGMS)- minimally invasive sensors that measure glucose concentrations at 5-min intervals over several days.
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 50 years and older
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At least 8th grade education
Exclusion Criteria:
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Diagnosed type 1 or type 2 diabetes
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Current use of mediation for diabetes (oral hypoglycemic agents, insulin), or with diabetic properties (e.g., steroids)
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Chronic disorders (cardiovascular disease, peripheral vascular disease, stroke, transient ischemic attack, chronic kidney disease, past year cancer)
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Neurological disorders (e.g., Parkinson's, epilepsy, multiple sclerosis)
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History of dementia or suspected dementia
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Known HIV
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Serious mental illness, psychosis, or use of psychotropic medication
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Heavy alcohol use
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Baltimore VA Geriatric Research Education and Clinical Center (GRECC) | Baltimore | Maryland | United States | 21201 |
Sponsors and Collaborators
- University of Maryland, Baltimore
- Baltimore Veterans Affairs Medical Center
- University of Maryland, Baltimore County
Investigators
- Principal Investigator: Tasneem Khambaty, PhD, University of Maryland, Baltimore County
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HP-00087044