A Study of the Functional Magnetic Resonance Imaging Response to Leptin and Pramlintide
This trial is active, not recruiting.
|Treatments||pramlintide (amylin), placebo (normal saline), 2 metreleptin, leptin plus pramlintide|
|Sponsor||Oregon Health and Science University|
|Start date||January 2006|
|End date||July 2012|
|Trial size||10 participants|
|Trial identifier||NCT00691158, OCTRI #933, eIRB #2168|
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.
|Endpoint classification||pharmacokinetics/dynamics study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
|Primary purpose||basic science|
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
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
Male or female participants from 18 years up to 45 years old.
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
|Official title||A Pilot Study of the fMRI Response to Leptin and Pramlintide|
|Principal investigator||Jonathan Q. Purnell, M.D.|
|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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