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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Joslin Diabetes Center
Sponsor:
Collaborator:
Abbott Diabetes Care
Information provided by (Responsible Party):
Howard Wolpert, Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT01283126
First received: January 24, 2011
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to find out the effects of low blood glucose on thinking processess in healthy individuals and how well changes in (interstitial) tissue glucose levels match up with changes in thinking in comparison to blood glucose levels.


Condition Intervention
Focus of Study is Cognitive Function During and After Hypoglycemia and to See if This Correlates Better With Blood or Interstitial Glucose Concentration.
Procedure: euglycemic and hypoglycemic clamp
Procedure: interstitial fluid measurement for glucose concentration
Device: continuous glucose monitor

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Blood/Interstitial Glucose Measurements and Cognitive Function During Hypoglycemia and Recovery

Resource links provided by NLM:


Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:
  • cognitive function correlation to blood or interstitial glucose [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Clamp
Subjects will complete clamp study visit.
Procedure: euglycemic and hypoglycemic clamp
A catheter will be inserted into an antecubital vein of the nondominant arm for the administration of insulin and dextrose (D20W). A second catheter will be placed retrogradely into a vein on the dorsal portion of the ipsilateral hand or wrist for blood sampling. The hand will be placed into a heated box (warmed to 70 degrees C) to arterialize the venous blood. Subjects will receive a primed continuous infusion of soluble insulin at 1.5mU•kg-1•min-1. The arterialized venous glucose levels will be measured every 5 minutes during the clamp, and the D20W infusion rate will be adjusted to maintain the target glucose level. During the control euglycemic clamp the glucose will be maintained at 90 mg/dl. For the hypoglycemic clamp study there will be an initial 60 minute euglycemic (90 mg/dl) phase, followed by hypoglycemia (45 mg/dl), then recovered euglycemia (90 mg/dl) lasting 70 minutes.
Procedure: interstitial fluid measurement for glucose concentration
This interstitial fluid will be obtained using a small abrasion and suction device.
Device: continuous glucose monitor
Small glucose sensor inserted into subcutaneous tissue to measure interstitial glucose level.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283126

Contacts
Contact: Astrid Atakov Castillo, BA 617-309-1997 Astrid.Atakov-Castillo@joslin.harvard.edu

Locations
United States, Massachusetts
Joslin Diabetes Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Astrid Atakov Castillo, BA    617-309-1997    Astrid.Atakov-Castillo@joslin.harvard.edu   
Contact: Shetty         
Principal Investigator: Howard Wolpert, MD         
Sub-Investigator: Greeshma K Shetty, MD         
Sub-Investigator: Gail Musen, PhD         
Sub-Investigator: Gail Adler, MD, PhD         
Sponsors and Collaborators
Joslin Diabetes Center
Abbott Diabetes Care
Investigators
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

No publications provided

Responsible Party: Howard Wolpert, Senior Physician, Joslin Diabetes Center; Director, Insulin Pump & Continuous Glucose Monitoring Programs, Joslin Diabetes Center; Assistant Professor, Harvard Medical School, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01283126     History of Changes
Other Study ID Numbers: CHS #: 2010-09
Study First Received: January 24, 2011
Last Updated: March 10, 2014
Health Authority: Joslin Committee on Human Studies: USA

Keywords provided by Joslin Diabetes Center:
cognitive function, hypoglycemia, interstitial glucose concentration, blood glucose concentration

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014