We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Hypothalamic Functional Magnetic Resonance Imaging (fMRI) Response to Nutrients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00686608
Recruitment Status : Unknown
Verified June 2012 by Jonathan Purnell, Oregon Health and Science University.
Recruitment status was:  Recruiting
First Posted : May 30, 2008
Last Update Posted : June 6, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to identify how certain parts of the brain that control appetite respond to changes in dietary carbohydrate and fat.

Condition or disease Intervention/treatment
Obesity Dietary Supplement: glucose Dietary Supplement: fructose Dietary Supplement: saline

Detailed Description:
To measure fMRI signal change in hypothalamic and brainstem centers associated with control of food intake and energy expenditure in response to IV glucose, fructose, and saline. The fMRI response to these nutrients will then be compared in obese vs. lean subjects. Frequently timed blood samples will be obtained for measurement of nutrients (i.e., glucose) and blood levels of other factors (i.e., insulin, ghrelin, lactate) during these infusion protocols, and to test associations between these levels and the fMRI response.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Hypothalamic fMRI Response to Nutrients
Study Start Date : October 2006
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012
Arms and Interventions

Arm Intervention/treatment
Experimental: Aim 1
To measure fMRI signal change in hypothalamic and brainstem centers associated with control of food intake and energy expenditure in response to 1) IV glucose 2) IV fructose 3) IV saline in both lean and obese subjects.
Dietary Supplement: glucose
0.3mg/kg of glucose
Dietary Supplement: fructose
fructose IV bolus
Dietary Supplement: saline
IV saline

Outcome Measures

Primary Outcome Measures :
  1. The primary outcomes of this aim will be the change in fMRI response in the hypothalamus to IV glucose, to IV glucose during intralipid infusion, and to the IV glucose alone, in the lean and obese groups separately. [ Time Frame: 0,1,2 and 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 18 year to 45 years of age
  • BMI 18 to 25 kg/m2 (25 subjects) and 30 to 40 kg/m2 (25 subjects), matched for age and sex.
  • 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, and seizure disorder.
  • Subjects who have lost weight as a result of dieting, pharmacological treatment, or bariatric surgery.
  • Weight > 350 lbs or girth > 60 inches (the limits of the MR machine)
  • Exercise > 30 minutes, 3 times a week.
  • Alcohol consumption > 2 drinks / day.
  • Weight > 300 lbs (150 kg) (weight limit for MR machine).
  • Blood glucose > 100 mg/dL, abnormal creatinine or liver function tests.
  • Illicit drug use.
  • Pregnancy.
  • Extreme dietary habits as determined by a GCRC nutritionist: very high or low dietary carbohydrate, protein, 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686608

Contact: Jonanthan Q. Purnell, M.D. 503-494-1056 purnellj@ohsu.edu

United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Jonathan Q. Purnell, M.D.    503-494-9516    purnellj@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
Principal Investigator: Jonathan Q. Purnell, M.D. Oregon Health and Science University
More Information

Responsible Party: Jonathan Purnell, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00686608     History of Changes
Other Study ID Numbers: eIRB #938
791 ( Other Identifier: Oregon Clinical and Translational Research Institute )
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012

Keywords provided by Jonathan Purnell, Oregon Health and Science University: