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

Sponsor
Oregon Health and Science University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00691158
Collaborator
(none)
10
Enrollment
1
Location
4
Arms
197.9
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Pramlintide (Amylin)
  • Drug: Placebo (Normal Saline)
  • Drug: 2 Metreleptin
  • Drug: Leptin plus Pramlintide
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
A Pilot Study of the fMRI Response to Leptin and Pramlintide
Study Start Date :
Jan 1, 2006
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 1- Normal Saline

4.7 mls normal saline IV bolus

Drug: Placebo (Normal Saline)
4.7 mls normal saline IV bolus x1
Other Names:
  • Placebo

    		•
    Active Comparator: 2 Metreleptin

    IV Leptin bolus

    Drug: 2 Metreleptin
    Receive .06mg/kg of metreleptin IV bolus x1
    Other Names:
  • Leptin

    		•
    Active Comparator: 3 Pramlintide

    IV Pramlintide bolus at Timpoint +0 and +30 minutes

    Drug: Pramlintide (Amylin)
    4.7 mls of Amylin 15mcg/ml IV bolus.
    Other Names:
  • Amylin

    		•
    Active Comparator: 4 Leptin plus Pramlintide

    leptin and pramlintide IV bolus injection at timpoints 0 and +30 minutes

    Drug: Leptin plus Pramlintide
    receive leptin IV bolus x1 and pramlintide bolus at Timepoint +0 and +30 minutes.
    Other Names:
  • Leptin and Amylin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To measure the fMRI response in the hypothalamus and brainstem, and whole brain, to intravenous leptin, pramlintide, combination leptin and pramlintide, and saline control. [over 90 minutes]

      measurements at each study time are include fMRI, blood draws and Visual Analog Score.

    Secondary Outcome Measures

    1. 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. [over 90 minutes]

      Blood samples are taken every 5 minutes from Timepoint +0 to Timepoint +60 and again one time at Timepoint +90

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oregon Health & Science University Portland Oregon United States 97239

    Sponsors and Collaborators

    • Oregon Health and Science University

    Investigators

    • Principal Investigator: Jonathan Q. Purnell, M.D., OHSU - Center for the Study of Weight Regulation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonathan Purnell, Principal Investigator, Oregon Health and Science University
    ClinicalTrials.gov Identifier:
    NCT00691158
    Other Study ID Numbers:
    • eIRB #2168
    • OCTRI #933
    First Posted:
    Jun 5, 2008
    Last Update Posted:
    Jul 29, 2021
    Last Verified:
    Jul 1, 2021
    Additional relevant MeSH terms:
    Pramlintide
    Islet Amyloid Polypeptide

    Study Results

    No Results Posted as of Jul 29, 2021