Overview

This trial is active, not recruiting.

Condition obesity
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Placebo Comparator)
4.7 mls normal saline IV bolus
placebo (normal saline) Placebo
4.7 mls normal saline IV bolus x1
(Active Comparator)
IV Leptin bolus
2 metreleptin Leptin
Receive .06mg/kg of metreleptin IV bolus x1
(Active Comparator)
IV Pramlintide bolus at Timpoint +0 and +30 minutes
pramlintide (amylin) Amylin
4.7 mls of Amylin 15mcg/ml IV bolus.
(Active Comparator)
leptin and pramlintide IV bolus injection at timpoints 0 and +30 minutes
leptin plus pramlintide Leptin and Amylin
receive leptin IV bolus x1 and pramlintide bolus at Timepoint +0 and +30 minutes.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.