Blood/Interstitial Glucose Measurements and Cognitive Function During Hypoglycemia and Recovery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01283126

Enrollment

Registered

2011-01-25

Start date

2011-01-31

Completion date

2015-10-31

Last updated

2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoglycemia

Keywords

Hypoglycemia, cognitive function

Brief summary

The purpose of this study is to find out the effects of hypoglycemia on cognition in healthy individuals and how well changes in (interstitial) tissue glucose levels correlate with changes in cognitive function as compared to blood glucose levels.

Detailed description

Subjects will undergo hypoglycemic clamps during which interstitial glucose will be measured and cognitive function will be assessed.

Interventions

PROCEDUREeuglycemic and hypoglycemic clamp

Subjects will undergo standard euglycemic and hypoglycemic clamps, and will have concurrent assessments of cognitive function and measurement of interstitial glucose concentrations.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* non obese (BMI \<30), ages 18-50

Exclusion criteria

* renal or hepatic failure * cancer or lymphoma * malabsorption or malnourishment * hypercortisolism * alcoholism or drug abuse * anemia * eating disorder or depression * coronary artery disease * Arrhythmias * hypertension * on medications known to affect the blood glucose to be measured such as * glucocorticoids * on blood thinning agents * Pregnant women, breastfeeding women and women who want to become pregnant in the next 6 months will be excluded from the study. * Subjects who have donated blood two weeks prior to the study. * Allergies to pig derived products (Heparin will be used)

Design outcomes

Primary

Measure	Time frame	Description
cognitive function correlation to blood or interstitial glucose	1 year	This investigator initiated study will evaluate cognitive function at the onset, during and following recovery from hypoglycemia and will determine if cognitive function correlates better with blood or interstitial glucose concentrations.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026