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Hypothalamic Functional Magnetic Resonance Imaging (fMRI) Response to Nutrients

Sponsor
Oregon Health and Science University (Other)
Overall Status
Completed
CT.gov ID
NCT00686608
Collaborator
(none)
56
Enrollment
1
Location
3
Arms
105
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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 Phase
  • Dietary Supplement: glucose
  • Dietary Supplement: fructose
  • Dietary Supplement: saline
 Phase 2

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
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Participants will receive infusions of glucose, fructose, and saline in a randomized order.Participants will receive infusions of glucose, fructose, and saline in a randomized order.
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Hypothalamic fMRI Response to Nutrients
Actual Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Glucose

IV glucose

Dietary Supplement: glucose
0.3mg/kg of glucose
Active Comparator: Fructose

Dietary Supplement: fructose
fructose IV bolus
Placebo Comparator: Saline

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. [0,1,2 and 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
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

Locations

Site City State Country Postal Code
1 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., Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jonathan Purnell, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00686608
Other Study ID Numbers:
  • eIRB #938
  • 791
First Posted:
May 30, 2008
Last Update Posted:
Aug 7, 2019
Last Verified:
Aug 1, 2019
Keywords provided by Jonathan Purnell, Principal Investigator, Oregon Health and Science University
Obesity
Additional relevant MeSH terms:
Obesity

Study Results

No Results Posted as of Aug 7, 2019