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

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. Identifier: NCT00691158
Recruitment Status : Active, not recruiting
First Posted : June 5, 2008
Last Update Posted : August 7, 2019
Information provided by (Responsible Party):
Jonathan Purnell, Oregon Health and Science University

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
Obesity Drug: Pramlintide (Amylin) Drug: Placebo (Normal Saline) Drug: 2 Metreleptin Drug: Leptin plus Pramlintide Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2006
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

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 Name: Placebo

Active Comparator: 2 Metreleptin
IV Leptin bolus
Drug: 2 Metreleptin
Receive .06mg/kg of metreleptin IV bolus x1
Other Name: 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 Name: 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 Name: Leptin and Amylin

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. [ Time Frame: 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. [ 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00691158

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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
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Principal Investigator: Jonathan Q. Purnell, M.D. OHSU - Center for the Study of Weight Regulation
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Responsible Party: Jonathan Purnell, Principal Investigator, Oregon Health and Science University Identifier: NCT00691158    
Other Study ID Numbers: eIRB #2168
OCTRI #933 ( Other Identifier: Oregon Health and Sciences University )
First Posted: June 5, 2008    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Islet Amyloid Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Amylin Receptor Agonists
Molecular Mechanisms of Pharmacological Action