Hypothalamic Functional Magnetic Resonance Imaging (fMRI) Response to Nutrients

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  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jonathan Purnell, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00686608
First received: May 28, 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 control appetite respond to changes in dietary carbohydrate and fat.


Condition Intervention
Obesity
Dietary Supplement: glucose
Dietary Supplement: fructose
Dietary Supplement: saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Hypothalamic fMRI Response to Nutrients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2006
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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
  • 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
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: NCT00686608

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

Locations
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
Investigators
Principal Investigator: Jonathan Q. Purnell, M.D. Oregon Health and Science University
  More Information

No publications provided

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
Study First Received: May 28, 2008
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014