Current partner codePEPTIDESDE
NCT00691158·Not applicable·INTERVENTIONAL

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

Status

Unknown

Phase

Not applicable

Enrollment

10

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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 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

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Jun 5, 2008

  2. Study start

    Jan 2006

  3. Primary completion

    Jul 2024

  4. Study completion

    Jul 2024

  5. Results posted

    Not reported

  6. Registry updated

    Dec 16, 2022

Outcomes

What the study measures.

Primary outcomes

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 outcomes

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
45 Years
Sex
ALL
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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Oregon Health & Science University

Portland, Oregon, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Pramlintide.

Related PeptideStat pages

Put the record in context.

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