Status:

UNKNOWN

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

Lead Sponsor:

Oregon Health and Science University

Conditions:

Obesity

Eligibility:

All Genders

18-45 years

Phase:

NA

Brief 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.

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2024

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT00691158

Start Date

January 1 2006

End Date

July 1 2024

Last Update

December 16 2022

Active Locations (1)

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Oregon Health & Science University

Portland, Oregon, United States, 97239