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

Not Applicable

Completed

• Conditions: Hypoglycemia
• Interventions: Procedure: euglycemic and hypoglycemic clamp

• Registration Number: NCT01283126
• Lead Sponsor: Joslin Diabetes Center

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-25
• Primary Completion: 2014-10
• Study Completion: 2015-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Euglycemic and hypoglycemic clamp	euglycemic and hypoglycemic clamp	Subjects will complete clamp study visit.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States