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

Not Applicable

Active, not recruiting

• Conditions: Obesity
• Interventions: Drug: 2 Metreleptin; Drug: Pramlintide (Amylin); Drug: Leptin plus Pramlintide; Drug: Placebo (Normal Saline)

• Registration Number: NCT00691158
• Lead Sponsor: Oregon Health and Science University

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 leptin and pramlintide.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-06-02
• Study First Submitted QC: 2008-06-04
• Study First Posted: 2008-06-05
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-16
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2 Metreleptin	2 Metreleptin	IV Leptin bolus
3 Pramlintide	Pramlintide (Amylin)	IV Pramlintide bolus at Timpoint +0 and +30 minutes
4 Leptin plus Pramlintide	Leptin plus Pramlintide	leptin and pramlintide IV bolus injection at timpoints 0 and +30 minutes
1- Normal Saline	Placebo (Normal Saline)	4.7 mls normal saline IV bolus

Primary Outcome Measures

Name	Time	Method
To measure the fMRI response in the hypothalamus and brainstem, and whole brain, to intravenous leptin, pramlintide, combination leptin and pramlintide, and saline control.	over 90 minutes	measurements at each study time are include fMRI, blood draws and Visual Analog Score.

Secondary Outcome Measures

Name	Time	Method
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.	over 90 minutes	Blood samples are taken every 5 minutes from Timepoint +0 to Timepoint +60 and again one time at Timepoint +90

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States