Healthy Volunteers Clinical Trial
Official title:
Insulin Modulation of fMRI Connectivity and Food Reward
Verified date | November 2017 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Body mass index between 18 and 24 - HOMA-IR < 1.55 (homeostatic model assessment of insulin resistance - ((glucose x insulin) / 405)). Exclusion Criteria: - Current or lifetime history of any cardiovascular disease or surgery (including hypertension, stroke, myocardial infarction, congestive heart failure, atrial or ventricular arrhythmias, coronary bypass, carotid artery, or peripheral vascular surgery) - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | During Taste Task in fMRI Scanner. Task Duration is approximately 14 minutes. |
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