Blood/Interstitial Glucose Measurements and Cognitive Function During Hypoglycemia and Recovery
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 24, 2011
CompletedFirst Posted
Study publicly available on registry
January 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedMay 9, 2017
May 1, 2017
3.8 years
January 24, 2011
May 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Euglycemic and hypoglycemic clamp
EXPERIMENTALSubjects will complete clamp study visit.
Interventions
Subjects will undergo standard euglycemic and hypoglycemic clamps, and will have concurrent assessments of cognitive function and measurement of interstitial glucose concentrations.
Eligibility Criteria
You may qualify if:
- non obese (BMI \<30), ages 18-50
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Joslin Diabetes Centerlead
- Abbott Diabetes Carecollaborator
Study Sites (1)
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2011
First Posted
January 25, 2011
Study Start
January 1, 2011
Primary Completion
October 1, 2014
Study Completion
October 1, 2015
Last Updated
May 9, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share