An Early Phase 1 interventional study of Insulin and Taste Task in Healthy Volunteers, sponsored by University of Pittsburgh. Withdrawn at 1 site in United States. Open to participants aged 21 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-04.
Sponsored by University of Pittsburgh · Early Phase 1, Interventional, and Basic science
This study evaluates the effects of changing insulin levels on brain activity. Participants will complete functional magnetic resonance imaging (fMRI) scans during fasting conditions, then during an insulin infusion.
Insulin is a hormone released by the pancreas in response to increases in glucose levels that result from food intake. In addition to stimulating glucose uptake in the periphery, insulin signals the central nervous system to induce satiety and inhibit feeding behavior.
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.
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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.
Drug: Insulin · Other: Taste Task · Other: Magnetic Resonance Imaging · Drug: Dextrose
Insulin will be administered peripherally to observe the effects of circulating insulin on brain activity
Also known as: HumuLIN®-R
Participants will taste milkshakes and a tasteless solution to observe the brain responses to palatable taste.
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.
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.
fMRI BOLD Response in Brain
The investigators will monitor the blood oxygen level dependent response using fMRI and compare activation during "taste" trials vs. "no taste" trials.
Time frame: During Taste Task in fMRI Scanner. Task Duration is approximately 14 minutes.
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2016 (actual). Primary completion is estimated for Dec 2017, 23 months after the start.
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This study is withdrawn, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Insulin