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

Primary Purpose

Hypoglycemia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

euglycemic and hypoglycemic clamp

About this trial

This is an interventional diagnostic trial for Hypoglycemia focused on measuring Hypoglycemia, cognitive function

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Joslin Diabetes Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Euglycemic and hypoglycemic clamp

Arm Description

Subjects will complete clamp study visit.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01283126

First Posted

January 24, 2011

Last Updated

May 4, 2017

Sponsor

Joslin Diabetes Center

Collaborators

Abbott Diabetes Care

1. Study Identification

Unique Protocol Identification Number

NCT01283126

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

January 2011 (Actual)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Joslin Diabetes Center

Collaborators

Abbott Diabetes Care

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoglycemia

Keywords

Hypoglycemia, cognitive function

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Euglycemic and hypoglycemic clamp

Arm Type

Experimental

Arm Description

Subjects will complete clamp study visit.

Intervention Type

Procedure

Intervention Name(s)

euglycemic and hypoglycemic clamp

Other Intervention Name(s)

clamp

Intervention Description

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

Primary Outcome Measure Information:

Title

cognitive function correlation to blood or interstitial glucose

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Howard Wolpert, MD

Organizational Affiliation

Joslin Diabetes Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Greeshma K Shetty, MD

Organizational Affiliation

Joslin Diabetes Center

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Gail Musen, PhD

Organizational Affiliation

Joslin Diabetes Center

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Gail Adler, MD, PhD

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Joslin Diabetes Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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