Recruiting

Observational Study

Sponsor:

University of Maryland, Baltimore

Code:

NCT04201600

Conditions

Glucose Metabolism Disorders (Including Diabetes Mellitus)

Cognitive Decline

Functional Status

PreDiabetes

Aging

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

Continuous Glucose Monitoring System (CGMS)

Study Details

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.

Conditions

Glucose Metabolism Disorders (Including Diabetes Mellitus)

Cognitive Decline

Functional Status

PreDiabetes

Aging

Study ID

NCT04201600

Start date

Mar 1, 2022

Status verified date

Mar, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Middle-aged and Older adults with Prediabetes

Middle-aged and Older adults with Prediabetes

Interventions

Continuous Glucose Monitoring System (CGMS)

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

Primary outcome measure

  • Aggregate Executive Functioning Score [ Time Frame: Day 10 ]
  • Aggregate Memory Score [ Time Frame: Day 10 ]
  • Aggregate Language Score [ Time Frame: Day 10 ]

Central Contacts and Locations

Central contacts

Kathleen Simpson

4106057179Kathleen.Simpson@va.gov

Ashley Splain, BA

asplain1@umbc.edu

Locations

Baltimore VA Geriatric Research Education and Clinical Center (GRECC)

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Tasneem Khambaty, PhD

410-455-2304khambaty@umbc.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Mar 30, 2025

Last verified

Mar, 2025

Keywords

  • Glucose Variability
  • Continuous Glucose Monitoring System (CGMS)
  • Prediabetes
  • Aging
  • Physical Functioning
  • Neurocognition
  • Cognitive Decline

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2025-03-30.