Insulin Modulation of fMRI Connectivity in Healthy Adults
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|ClinicalTrials.gov Identifier: NCT02982551|
Recruitment Status : Withdrawn (Principal Investigator Departed University)
First Posted : December 5, 2016
Last Update Posted : December 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Insulin Other: Taste Task Other: Magnetic Resonance Imaging Drug: Dextrose||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Insulin Modulation of fMRI Connectivity and Food Reward|
|Actual Study Start Date :||January 1, 2016|
|Estimated Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Experimental: 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 will be administered peripherally to observe the effects of circulating insulin on brain activity
Other Name: HumuLIN®-R
Other: Taste Task
Participants will taste milkshakes and a tasteless solution to observe the brain responses to palatable taste.
Other: 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.
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 [ Time Frame: During Taste Task in fMRI Scanner. Task Duration is approximately 14 minutes. ]The investigators will monitor the blood oxygen level dependent response using fMRI and compare activation during "taste" trials vs. "no taste" trials.
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): NCT02982551
|United States, Pennsylvania|
|Western Psychiatric Institute and Clinic|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||John P Ryan, PhD||University of Pittsburgh|