Insulin Modulation of fMRI Connectivity in Healthy Adults

NCT02982551 | Withdrawn Early Phase 1

• 1 other identifier: PRO15040502
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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.

Drug: Insulin; Other: Taste Task; Other: Magnetic Resonance Imaging; Drug: Dextrose

Interventions

Insulin DRUG

Insulin will be administered peripherally to observe the effects of circulating insulin on brain activity

Also known as: HumuLIN®-R

Hyperinsulinemic Clamp

Taste Task OTHER

Participants will taste milkshakes and a tasteless solution to observe the brain responses to palatable taste.

Hyperinsulinemic Clamp

Magnetic Resonance Imaging OTHER

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.

Hyperinsulinemic Clamp

Dextrose DRUG

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.

Hyperinsulinemic Clamp

Eligibility Criteria

• Age: 21 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index between 18 and 24
• HOMA-IR \< 1.55 (homeostatic model assessment of insulin resistance - ((glucose x insulin) / 405)).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

Insulin; Magnetic Resonance Spectroscopy; Glucose

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• John P Ryan, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: December 5, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 4, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)