Glucose Variability and Cognition in Prediabetes

Relations of Glucose Variability With Cognitive Function and Functional Status Among Older Adults at Risk for Diabetes

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; PreDiabetes; Aging; Cognitive Decline; Functional Status; Glucose Metabolism Disorders (Including Diabetes Mellitus)
• Intervention / Treatment: Device: Continuous Glucose Monitoring System (CGMS)

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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Tasneem Khambaty, PhD; Phone Number: 410.455.2304; Email: khambaty@umbc.edu
• Study Contact Backup: Name: Ashley Splain, BA; Email: asplain1@umbc.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • Baltimore VA Geriatric Research Education and Clinical Center (GRECC)
      • Contact: Tasneem Khambaty, PhD; Phone Number: 410-455-2304; Email: khambaty@umbc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults aged 50 years and older with prediabetes of any duration

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aggregate Physical Functioning Score	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	Day 10
Activities of Daily Living (ADL) total score	Responses on this standard measure will be scored according to guidelines to create a total score for functional status	Day 10
Instrumental Activities of Daily Living (IADL) total score	Responses on this standard measure will be scored according to guidelines to create a total score for functional status	Day 10

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: University of Maryland, Baltimore County; Baltimore Veterans Affairs Medical Center
• Investigators: Principal Investigator: Tasneem Khambaty, PhD, University of Maryland, Baltimore County

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): November 30, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 14, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Prediabetes; Aging; Neurocognition; Cognitive Decline; Physical Functioning; Glucose Variability; Continuous Glucose Monitoring System (CGMS)
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Cognition Disorders; Prediabetic State; Glucose Intolerance; Cognitive Dysfunction; Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: HP-00087044

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes