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

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.

Completed

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Key information

Conditions

Hypoglycemia Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

euglycemic and hypoglycemic clamp

Procedure

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

Other names: clamp

Primary outcomes

cognitive function correlation to blood or interstitial glucose

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

Abbott Diabetes Care

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2015
First posted: Jan 25, 2011
Registry last updated: May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed