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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Oregon Health and Science University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Jonathan Purnell, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00691158
First received: June 2, 2008
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Obesity
Drug: Pramlintide (Amylin)
Drug: Placebo (Normal Saline)
Drug: 2 Metreleptin
Drug: Leptin plus Pramlintide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Pilot Study of the fMRI Response to Leptin and Pramlintide

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    measurements at each study time are include fMRI, blood draws and Visual Analog Score.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Blood samples are taken every 5 minutes from Timepoint +0 to Timepoint +60 and again one time at Timepoint +90


Estimated Enrollment: 10
Study Start Date: January 2006
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1- Normal Saline
4.7 mls normal saline IV bolus
Drug: Placebo (Normal Saline)
4.7 mls normal saline IV bolus x1
Other Name: Placebo
Active Comparator: 2 Metreleptin
IV Leptin bolus
Drug: 2 Metreleptin
Receive .06mg/kg of metreleptin IV bolus x1
Other Name: Leptin
Active Comparator: 3 Pramlintide
IV Pramlintide bolus at Timpoint +0 and +30 minutes
Drug: Pramlintide (Amylin)
4.7 mls of Amylin 15mcg/ml IV bolus.
Other Name: Amylin
Active Comparator: 4 Leptin plus Pramlintide
leptin and pramlintide IV bolus injection at timpoints 0 and +30 minutes
Drug: Leptin plus Pramlintide
receive leptin IV bolus x1 and pramlintide bolus at Timepoint +0 and +30 minutes.
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691158

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Jonathan Q. Purnell, M.D. OHSU - Center for the Study of Weight Regulation
  More Information

No publications provided

Responsible Party: Jonathan Purnell, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00691158     History of Changes
Other Study ID Numbers: eIRB #2168, OCTRI #933
Study First Received: June 2, 2008
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pramlintide
Islet Amyloid Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014