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

NCT ID: NCT00691158

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1- Normal Saline

4.7 mls normal saline IV bolus

Group Type PLACEBO_COMPARATOR

Placebo (Normal Saline)

Intervention Type DRUG

4.7 mls normal saline IV bolus x1

2 Metreleptin

IV Leptin bolus

Group Type ACTIVE_COMPARATOR

2 Metreleptin

Intervention Type DRUG

Receive .06mg/kg of metreleptin IV bolus x1

3 Pramlintide

IV Pramlintide bolus at Timpoint +0 and +30 minutes

Group Type ACTIVE_COMPARATOR

Pramlintide (Amylin)

Intervention Type DRUG

4.7 mls of Amylin 15mcg/ml IV bolus.

4 Leptin plus Pramlintide

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

Group Type ACTIVE_COMPARATOR

Leptin plus Pramlintide

Intervention Type DRUG

receive leptin IV bolus x1 and pramlintide bolus at Timepoint +0 and +30 minutes.

Interventions

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Pramlintide (Amylin)

4.7 mls of Amylin 15mcg/ml IV bolus.

Intervention Type DRUG

Placebo (Normal Saline)

4.7 mls normal saline IV bolus x1

Intervention Type DRUG

2 Metreleptin

Receive .06mg/kg of metreleptin IV bolus x1

Intervention Type DRUG

Leptin plus Pramlintide

receive leptin IV bolus x1 and pramlintide bolus at Timepoint +0 and +30 minutes.

Intervention Type DRUG

Other Intervention Names

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Amylin Placebo Leptin Leptin and Amylin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Purnell

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonathan Q. Purnell, M.D.

Role: PRINCIPAL_INVESTIGATOR

OHSU - Center for the Study of Weight Regulation

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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OCTRI #933

Identifier Type: OTHER

Identifier Source: secondary_id

eIRB #2168

Identifier Type: -

Identifier Source: org_study_id