Healthy VolunteersEarly Phase 1NCT02982551
Insulin Modulation of fMRI Connectivity in Healthy Adults
A Early Phase 1 study testing Insulin, Taste Task and Magnetic Resonance Imaging in people with Healthy Volunteers, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Insulin, Taste Task and Magnetic Resonance Imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to Dec 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index between 18 and 24
- HOMA-IR < 1.55 (homeostatic model assessment of insulin resistance - ((glucose x insulin) / 405)).
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Insulin Modulation of fMRI Connectivity and Food Reward
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Insulin, Taste Task, Magnetic Resonance Imaging, Dextrose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Also called HumuLIN®-R
Insulin will be administered peripherally to observe the effects of circulating insulin on brain activity
Taste TaskOther
Participants will taste milkshakes and a tasteless solution to observe the brain responses to palatable taste.
Magnetic Resonance ImagingOther
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.
DextroseDrug
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 group | Role | What they receive |
|---|---|---|
| Hyperinsulinemic Clamp | Experimental | 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. Receives: Drug: Insulin; Other: Taste Task; Other: Magnetic Resonance Imaging; Drug: Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During Taste Task in fMRI Scanner. Task Duration is approximately 14 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start1 Jan 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017
Why it stopped: Principal Investigator Departed University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Patrick Ryan, University of Pittsburgh
- Investigators
- John P Ryan, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982551
- Sponsor's protocol ID
- PRO15040502
- Status last verified
- Nov 2017
- First submitted
- 22 Nov 2016
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Modulation of fMRI Connectivity and Food Reward
- ClinicalTrials.gov ID
- NCT02982551
- Acronym / sponsor ID
- PRO15040502
- Conditions
- Healthy Volunteers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator Departed University
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperinsulinemic Clamp | Experimental | Drug: Insulin, Other: Taste Task, Other: Magnetic Resonance Imaging, Drug: DextroseParticipants 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. |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index between 18 and 24
- HOMA-IR < 1.55 (homeostatic model assessment of insulin resistance - ((glucose x insulin) / 405)).
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InsulinAlso: HumuLIN®-RInsulin will be administered peripherally to observe the effects of circulating insulin on brain activity | Drug | Hyperinsulinemic Clamp |
| Taste TaskParticipants will taste milkshakes and a tasteless solution to observe the brain responses to palatable taste. | Other | Hyperinsulinemic Clamp |
| Magnetic Resonance ImagingParticipants 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. | Other | Hyperinsulinemic Clamp |
| DextroseDuring 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. | Drug | Hyperinsulinemic Clamp |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John P Ryan, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Insulin, Taste Task and Magnetic Resonance Imaging in people with Healthy Volunteers, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI BOLD Response in Brain (time frame: During Taste Task in fMRI Scanner. Task Duration is approximately 14 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2017.