Glucose Variability and Cognition in Prediabetes

NCT04201600 | Recruiting DMC FDA Device

• 1 other identifier: HP-00087044
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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; Depression

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Aggregate Executive Functioning Score

  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)

  Day 10

• Aggregate Memory Score

  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

  Day 10

• Aggregate Language Score

  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)

  Day 10

Secondary Outcomes (3)

• Aggregate Physical Functioning Score

  Day 10

• Activities of Daily Living (ADL) total score

  Day 10

• Instrumental Activities of Daily Living (IADL) total score

  Day 10

Study Arms (1)

Middle-aged and Older adults with Prediabetes

Middle-aged and Older adults with Prediabetes

Device: Continuous Glucose Monitoring System (CGMS)

Interventions

Continuous Glucose Monitoring System (CGMS) DEVICE

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

Middle-aged and Older adults with Prediabetes

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 50 years and older with prediabetes of any duration

You may qualify if:

• Aged 50 years and older
• At least 8th grade education

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Baltimore VA Medical Center: collaborator
• University of Maryland, Baltimore County: collaborator

Study Sites (1)

Baltimore VA Geriatric Research Education and Clinical Center (GRECC)

Baltimore, Maryland, 21201, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples, inflammatory markers, fasting glucose

MeSH Terms

Conditions

Glucose Metabolism Disorders; Cognitive Dysfunction; Prediabetic State; Depression

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Diabetes Mellitus; Endocrine System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Tasneem Khambaty, PhD

  University of Maryland, Baltimore County

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen Simpson

CONTACT

4106057179; Kathleen.Simpson@va.gov

Ashley Splain, BA

CONTACT

asplain1@umbc.edu

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 17, 2019
• Study Start: March 1, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)