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

NCT ID: NCT01283126

Last Updated: 2017-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-10-31

Brief Summary

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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

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

Conditions

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Hypoglycemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Euglycemic and hypoglycemic clamp

Subjects will complete clamp study visit.

Group Type EXPERIMENTAL

euglycemic and hypoglycemic clamp

Intervention Type PROCEDURE

Subjects will undergo standard euglycemic and hypoglycemic clamps, and will have concurrent assessments of cognitive function and measurement of interstitial glucose concentrations.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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clamp

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Diabetes Care

INDUSTRY

Sponsor Role collaborator

Joslin Diabetes Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Howard Wolpert, MD

Role: PRINCIPAL_INVESTIGATOR

Joslin Diabetes Center

Greeshma K Shetty, MD

Role: STUDY_CHAIR

Joslin Diabetes Center

Gail Musen, PhD

Role: STUDY_CHAIR

Joslin Diabetes Center

Gail Adler, MD, PhD

Role: STUDY_CHAIR

Brigham and Women's Hospital

Locations

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Joslin Diabetes Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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CHS #: 2010-09

Identifier Type: -

Identifier Source: org_study_id

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