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

Hypoglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01283126
• Other study ID #: CHS #: 2010-09
• Status: Completed
• Phase: N/A
• First received: January 24, 2011
• Last updated: May 4, 2017
• Start date: January 2011
• Est. completion date: October 2015

Study information

• Verified date: May 2017
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypoglycemia

Intervention

Procedure:
• euglycemic 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.

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Joslin Diabetes Center	Abbott Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive function correlation to blood or interstitial glucose	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.	1 year