Insulin Modulation of fMRI Connectivity in Healthy Adults
NCT ID: NCT02982551
Last Updated: 2017-12-04
Study Results
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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WITHDRAWN
EARLY_PHASE1
INTERVENTIONAL
2016-01-01
2017-12-31
Brief Summary
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Detailed Description
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To begin to identify the specific effects of circulating insulin on brain networks, the current study will recruit healthy participants who will undergo two functional magnetic resonance imaging scans. One scan will be performed in the fasted state, and the alternate scan will be conducted during an isoglycemic hyperinsulinemic clamp.
This project will allow us to identify the specific effects of circulating insulin on brain reactivity to palatable food.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Hyperinsulinemic Clamp
Participants will complete two MRI scans approximately one hour apart - one under baseline conditions and the second during an insulin infusion. Each scan will include data collected during rest, and a taste task. The taste task involves receiving milkshake or a tasteless solution. After the first scan, an isoglycemic-hyperinsulinemic clamp will be implemented. An IV will be placed in the antecubital vein of of arm for infusion of insulin and dextrose. HumuLIN®-R regular insulin will be infused at 40 mU/m2/min. A second IV will be inserted in the back of the hand on the opposite arm to allow for frequent sampling of blood glucose levels. Dextrose infusion will be used to keep the blood sugar level within 5mg/dl of the baseline value. The study team will monitor blood glucose levels and adjust dextrose infusions as necessary. Thirty minutes after starting the insulin infusion, participants will be moved back into the bore of the MRI scanner for the repeat scans.
Insulin
Insulin will be administered peripherally to observe the effects of circulating insulin on brain activity
Taste Task
Participants will taste milkshakes and a tasteless solution to observe the brain responses to palatable taste.
Magnetic Resonance Imaging
Participants will complete two MRI scans approximately 60 minutes apart - one under baseline fasting conditions and the second during isoglycemic-hyperinsulinemia. Each functional scan will include a resting-state BOLD sequence followed by a taste-reward task. Functional MRI sequences will last approximately 30 minutes. MRI scanning will also include approximately 30 minutes of structural MRI scans.
Dextrose
During hyperinsulinemic clamp, participants will be infused with a variable rate dextrose infusion will be used to keep the blood sugar level within 5mg/dl of the baseline glucose value.
Interventions
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Insulin
Insulin will be administered peripherally to observe the effects of circulating insulin on brain activity
Taste Task
Participants will taste milkshakes and a tasteless solution to observe the brain responses to palatable taste.
Magnetic Resonance Imaging
Participants will complete two MRI scans approximately 60 minutes apart - one under baseline fasting conditions and the second during isoglycemic-hyperinsulinemia. Each functional scan will include a resting-state BOLD sequence followed by a taste-reward task. Functional MRI sequences will last approximately 30 minutes. MRI scanning will also include approximately 30 minutes of structural MRI scans.
Dextrose
During hyperinsulinemic clamp, participants will be infused with a variable rate dextrose infusion will be used to keep the blood sugar level within 5mg/dl of the baseline glucose value.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HOMA-IR \< 1.55 (homeostatic model assessment of insulin resistance - ((glucose x insulin) / 405)).
Exclusion Criteria
* Current or lifetime history of cancer, a chronic kidney or liver condition, type I or II diabetes, or any pulmonary or respiratory disease
* Current or lifetime diagnoses of any substance abuse
* Positive urine drug screen
* Current or lifetime use of glucocorticoid medications for \>1 month
* A previous cerebrovascular accident or trauma involving loss of consciousness
* Previous neurosurgery or history of a neurological condition
* Pregnancy (females)
* Claustrophobia
* Ferrous metallic implants or any surgically placed medical device not cleared for safety at 3Tesla MRI strength
* Peripheral vascular disease
* Liver, kidney, or active blood disease
* Peripheral neuropathy
* Anemia (hematocrit \<34%)
* Inability and/or willingness to comply with the protocol as written
* Fasting glucose \> 126 mg/dL
* Currently taking blood thinners such as coumadin, Lovenox, etc.
* Currently taking any medications that can alter glucose homeostasis (steroids, glucocorticoids, nicotinic acid)
* Current use of any psychotropic medications (SSRI, SNRI, etc.)
* Currently taking thiazolidinediones or insulin
* Currently use of statins or anti-hypertensive medications
* Use of medications related to HIV that can affect insulin sensitivity. We will NOT specifically test for HIV serostatus.
* Females currently on hormone replacement therapy (HRT) less than 6 months
* Participants will be instructed to abstain from eating, drinking (other than water), smoking and exercise for the 12 hours prior to each study visit.
* Being left handed
* Body mass index above 24 or below 18
* Milk allergy / lactose intolerance
* Polycystic ovary syndrome
21 Years
30 Years
ALL
Yes
Sponsors
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University of Pittsburgh
OTHER
Responsible Party
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John Patrick Ryan
PhD
Principal Investigators
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John P Ryan, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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PRO15040502
Identifier Type: -
Identifier Source: org_study_id