Glucose Variability and Cognition in Prediabetes

NCT ID: NCT04201600

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Glucose Metabolism Disorders (Including Diabetes Mellitus) Cognitive Decline Functional Status PreDiabetes Aging Depression

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Middle-aged and Older adults with Prediabetes

Middle-aged and Older adults with Prediabetes

Continuous Glucose Monitoring System (CGMS)

Intervention Type DEVICE

Continuous Glucose Monitoring System (CGMS)- minimally invasive sensors that measure glucose concentrations at 5-min intervals over several days.

Interventions

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Continuous Glucose Monitoring System (CGMS)

Continuous Glucose Monitoring System (CGMS)- minimally invasive sensors that measure glucose concentrations at 5-min intervals over several days.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Baltimore VA Medical Center

FED

Sponsor Role collaborator

University of Maryland, Baltimore County

OTHER

Sponsor Role collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Leslie Katzel

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tasneem Khambaty, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore County

Locations

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Baltimore VA Geriatric Research Education and Clinical Center (GRECC)

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kathleen Simpson

Role: CONTACT

4106057179

Ashley Splain, BA

Role: CONTACT

Facility Contacts

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Tasneem Khambaty, PhD

Role: primary

410-455-2304

Other Identifiers

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HP-00087044

Identifier Type: -

Identifier Source: org_study_id

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