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Insulin Modulation of fMRI Connectivity in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02982551
Recruitment Status : Withdrawn (Principal Investigator Departed University)
First Posted : December 5, 2016
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
John Patrick Ryan, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE November 22, 2016
First Posted Date  ICMJE December 5, 2016
Last Update Posted Date December 4, 2017
Actual Study Start Date  ICMJE January 1, 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02982551 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Insulin Modulation of fMRI Connectivity in Healthy Adults
Official Title  ICMJE Insulin Modulation of fMRI Connectivity and Food Reward
Brief Summary 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Insulin
    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.
  • Drug: 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.
Study Arms  ICMJE 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.
Interventions:
  • Drug: Insulin
  • Other: Taste Task
  • Other: Magnetic Resonance Imaging
  • Drug: Dextrose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 30, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2016)
10
Actual Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02982551
Other Study ID Numbers  ICMJE PRO15040502
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party John Patrick Ryan, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John P Ryan, PhD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP