A Study of the Functional Magnetic Resonance Imaging Response to Leptin and Pramlintide

Overview

The purpose of this study is to identify how certain parts of the brain that help control body weight respond to an infusion of hormones called leptin and amylin.

Full Title of Study: “A Pilot Study of the fMRI Response to Leptin and Pramlintide”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2020

Detailed Description

Following an overnight fast, subjects will undergo fMRI measurements of the hypothalamus, brainstem and whole brain during an infusion of either normal saline, pramlintide, leptin, or the combination leptin and pramlintide.

Interventions

  • Drug: Pramlintide (Amylin)
    • 4.7 mls of Amylin 15mcg/ml IV bolus.
  • Drug: Placebo (Normal Saline)
    • 4.7 mls normal saline IV bolus x1
  • Drug: 2 Metreleptin
    • Receive .06mg/kg of metreleptin IV bolus x1
  • Drug: Leptin plus Pramlintide
    • receive leptin IV bolus x1 and pramlintide bolus at Timepoint +0 and +30 minutes.

Arms, Groups and Cohorts

  • Placebo Comparator: 1- Normal Saline
    • 4.7 mls normal saline IV bolus
  • Active Comparator: 2 Metreleptin
    • IV Leptin bolus
  • Active Comparator: 3 Pramlintide
    • IV Pramlintide bolus at Timpoint +0 and +30 minutes
  • Active Comparator: 4 Leptin plus Pramlintide
    • leptin and pramlintide IV bolus injection at timpoints 0 and +30 minutes

Clinical Trial Outcome Measures

Primary Measures

  • To measure the fMRI response in the hypothalamus and brainstem, and whole brain, to intravenous leptin, pramlintide, combination leptin and pramlintide, and saline control.
    • Time Frame: over 90 minutes
    • measurements at each study time are include fMRI, blood draws and Visual Analog Score.

Secondary Measures

  • Timed blood samples during infusion will establish the time course for peak levels of infused hormones as well as detectable changes in insulin and glucose levels.
    • Time Frame: over 90 minutes
    • Blood samples are taken every 5 minutes from Timepoint +0 to Timepoint +60 and again one time at Timepoint +90

Participating in This Clinical Trial

Inclusion Criteria

  • Age 18 year to 45 years of age
  • MI 18 to 25 kg/m2 or ≥ 30 kg/m2
  • At maximal lifetime weight
  • Weight stable for at least 3 months

Exclusion Criteria

  • Those with a major medical illness or who require prescription medication, including: cancer, coronary artery disease, hypertension, and diabetes.
  • Subjects taking psychiatric or centrally-acting (CNS) medications or who are diagnosed with a psychiatric or neurological illness, including:
  • depression
  • anorexia
  • bulimia
  • seizure disorder.
  • Exercise > 30 minutes, 3 times a week
  • Alcohol consumption > 2 drinks / day
  • Weight > 350 lbs (159 kg) (weight limit for MR machine)
  • Illicit drug use
  • Pregnancy
  • Extreme dietary habits as determined by a GCRC nutritionist: very high or low dietary carbohydrate or fat intakes
  • Those with a contraindication to exposure to strong magnetic fields: presence of metal in the body such as body piercing, shrapnel, cardiac pacemakers or aneurysm clips
  • Those with claustrophobia
  • Anaphylaxis and known hypersensitivity to E. coli-derived proteins
  • Allergies or contraindications to metreleptin or pramlintide
  • Renal or hepatic impairment
  • Women who are lactating
  • Tobacco use

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Oregon Health and Science University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jonathan Purnell, Principal Investigator – Oregon Health and Science University
  • Overall Official(s)
    • Jonathan Q. Purnell, M.D., Principal Investigator, OHSU – Center for the Study of Weight Regulation

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