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
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
|Study Type :||Observational|
|Actual Enrollment :||9 participants|
|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|
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
- 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.
- 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
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
|United States, Connecticut|
|PET Center, YCCI Hospital Research Unit (HRU)|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Renata Belfort De Aguiar, MD||Yale University|