Clinical trial NCT04201600: Glucose Variability and Cognition in Prediabetes
Official title: Relations of Glucose Variability with Cognitive Function and Functional Status Among Older Adults At Risk for Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus)
Cognitive Decline
Functional Status
PreDiabetes
Aging
Depression
Keywords: Glucose Variability
Continuous Glucose Monitoring System (CGMS)
Prediabetes
Aging
Physical Functioning
Neurocognition
Cognitive Decline
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Baltimore VA Medical Center
name: University of Maryland, Baltimore County
First posted: 2019-12-17
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 50 years and older with prediabetes of any duration

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.

Eligibility criteria: 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

Primary outcomes:
measure: Aggregate Executive Functioning Score
timeFrame: Day 10
measure: Aggregate Memory Score
timeFrame: Day 10
measure: Aggregate Language Score
timeFrame: Day 10
Secondary outcomes:
measure: Aggregate Physical Functioning Score
timeFrame: Day 10
measure: Activities of Daily Living (ADL) total score
timeFrame: Day 10
measure: Instrumental Activities of Daily Living (IADL) total score
timeFrame: Day 10
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Geriatric Research Education and Clinical Center (GRECC)
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore County
name: Tasneem Khambaty, PhD
role: PRINCIPAL_INVESTIGATOR
References: