DRUG
Pramlintide (Amylin)
4.7 mls of Amylin 15mcg/ml IV bolus.
Status
Unknown
Phase
Not applicable
Enrollment
10
Locations
1
Results
Not posted
Publications
0
Study 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.
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
4.7 mls of Amylin 15mcg/ml IV bolus.
DRUG
4.7 mls normal saline IV bolus x1
DRUG
Receive .06mg/kg of metreleptin IV bolus x1
DRUG
receive leptin IV bolus x1 and pramlintide bolus at Timepoint +0 and +30 minutes.
Timeline
First posted
Jun 5, 2008
Study start
Jan 2006
Primary completion
Jul 2024
Study completion
Jul 2024
Results posted
Not reported
Registry updated
Dec 16, 2022
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.
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
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
United States. Showing up to 24 locations stored in the fast local snapshot.
Oregon Health & Science University
Portland, Oregon, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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