Hypothalamic Functional Magnetic Resonance Imaging (fMRI) Response to Nutrients
This study is currently recruiting participants.
Verified June 2012 by Oregon Health and Science University
Sponsor:
Oregon Health and Science University
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
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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
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 May 21, 2013