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Evaluation of the Effect of Hypoglycemia With PET and a Norepinephrine Transporter Ligand

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ClinicalTrials.gov Identifier: NCT02056249
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:

The aim of this study is to use Positron Emission Tomography (PET) imaging to measure changes in norepinephrine transporter (NET) concentrations in the brain and periphery of healthy individuals during hypoglycemia.

We hypothesize that during hypoglycemia, NE levels will increase within the brain, especially the hypothalamus, and this likely contributes to activation of glucose counterregulatory responses. We further hypothesize that during hypoglycemia, NET concentrations in key glucoregulatory regions will change in order to sustain or prolong sympathetic nervous system activation of counterregulatory responses.


Condition or disease Intervention/treatment
Hypoglycemia Other: Norepinephrine Transporter (NET) ligand

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Evaluation of the Effect of Hypoglycemia on the Noradrenergic System With PET and a Highly Selective Norepinephrine Transporter Ligand
Study Start Date : June 2011
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Group/Cohort Intervention/treatment
Healthy, lean subjects
Volunteers without anemia (hematocrit), diabetes (A1c), use of illicit drugs and antidepressants, or any other major health issues.
Other: Norepinephrine Transporter (NET) ligand
Norepinephrine Transporter (NET) ligand for iv administration during Positron Emission Tomography scan to measure changes in brain NET concentration based on insulin levels.
Other Name: [11C]MRB




Primary Outcome Measures :
  1. norepinephrine transporter (NET) ligand concentrations at Baseline [ Time Frame: 4-8 weeks from initial screening ]
    An IV catheter may be inserted in the other hand to allow drawing of continuous blood for measurement of tracer kinetics. PET scans will be done as subjects rest, the tracer will be injected, and initial data will be acquired on the scanner.

  2. norepinephrine transporter (NET) ligand concentrations in hyperinsulinemic-hypoglycemic Condition [ Time Frame: 4-8 weeks from initial screening ]
    Once baseline study has been completed, a continuous intravenous infusion of insulin (2mU/kg/min) will be started along with a variable infusion of 20% glucose to lower and maintain plasma glucose levels ~55 mg/dL for 30 min before the second injection of [the tracer and PET scanning. The hyperinsulinemic-hypoglycemic glucose clamp will continue throughout the 2nd PET study (90-120 min for brain and ~30 min for periphery).


Biospecimen Retention:   Samples With DNA
whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Potentially eligible subjects (healthy controls) will be recruited through flyers and the Yale web site for this pilot project.
Criteria

Inclusion Criteria:

  1. Males or females between 18 and 55 years of age
  2. Who are able to give voluntary written informed consent
  3. Able to tolerate PET and MR imaging
  4. Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
  5. Have no current uncontrolled medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology
  6. Have no history of a neurological or psychiatric disorder
  7. No history of previous allergic reactions to drugs
  8. Do not suffer from claustrophobia or any MRI contradictions

Exclusion Criteria:

  1. History of liver disease
  2. Pregnancy/breast feeding (as documented by pregnancy testing at screening and on days of the imaging studies).
  3. Anemia (Hct <37 in women and < 40 in men)
  4. Presence of acute or unstable medical or neurological illness. Subjects will be excluded from the study if they present with any history of serious medical or neurological illness or if they show signs of a major medical or neurological illness on examination or lab testing including history of seizures, head injury, brain tumor, heart, liver or kidney disease, eating disorder, diabetes.
  5. Drug abuse (except nicotine)(Nicotine dependence will be permitted in all groups but controlled for in the analysis).
  6. Use of antidepressants.
  7. Clotting disorders or recent anticoagulant therapy.
  8. MRI-incompatible implants and other contraindications for MRI, such as pace-maker, artificial joints, non-removable body piercings, tattoos larger than 1 cm in diameter, claustrophobia, etc
  9. Clinically significant pulmonary, renal, cardiac or hepatic impairment or cancer, have clinically significant infectious disease, including AIDS or HIV infection, or previous positive test for hepatitis B, hepatitis C, HIV-1, or HIV-2; subjects will be asked about this. No testing will be performed.
  10. Have received a diagnostic or therapeutic radiopharmaceutical within 7 days prior to participation in this study.
  11. Blood donation during the 8-week period preceding the PET scan.
  12. Participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits for normal volunteers.
  13. Unable to fast overnight prior to the PET scan.

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): NCT02056249


Locations
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United States, Connecticut
PET Center, YCCI Hospital Research Unit (HRU)
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Renata Belfort De Aguiar, MD Yale University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02056249     History of Changes
Other Study ID Numbers: 1103008163
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

Keywords provided by Yale University:
hypoglycemia
Positron Emission Tomography
norepinephrine transporter

Additional relevant MeSH terms:
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Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Norepinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents