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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2014

Detailed Description

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

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Euglycemic and hypoglycemic clamp
    • Subjects will complete clamp study visit.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Joslin Diabetes Center
  • Collaborator
    • Abbott Diabetes Care
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Howard Wolpert, MD, Principal Investigator, Joslin Diabetes Center
    • Greeshma K Shetty, MD, Study Chair, Joslin Diabetes Center
    • Gail Musen, PhD, Study Chair, Joslin Diabetes Center
    • Gail Adler, MD, PhD, Study Chair, Brigham and Women’s Hospital

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