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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01283126
Recruitment Status : Completed
First Posted : January 25, 2011
Last Update Posted : May 9, 2017
Sponsor:
Collaborator:
Abbott Diabetes Care
Information provided by (Responsible Party):
Joslin Diabetes Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypoglycemia Procedure: euglycemic and hypoglycemic clamp Not Applicable

Detailed Description:
Subjects will undergo hypoglycemic clamps during which interstitial glucose will be measured and cognitive function will be assessed.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Blood/Interstitial Glucose Measurements and Cognitive Function During Hypoglycemia and Recovery
Actual Study Start Date : January 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Euglycemic and hypoglycemic clamp
Subjects will complete clamp study visit.
 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.
Other Name: clamp


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283126


Locations
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United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
Abbott Diabetes Care
Investigators
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Principal Investigator: Howard Wolpert, MD Joslin Diabetes Center
Study Chair: Greeshma K Shetty, MD Joslin Diabetes Center
Study Chair: Gail Musen, PhD Joslin Diabetes Center
Study Chair: Gail Adler, MD, PhD Brigham and Women's Hospital
More Information
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Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01283126    
Other Study ID Numbers: CHS #: 2010-09
First Posted: January 25, 2011    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Joslin Diabetes Center:
Hypoglycemia, cognitive function
Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs