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Clinical Trials/NCT00686608
NCT00686608
Completed
Phase 2

Hypothalamic fMRI Response to Nutrients

Oregon Health and Science University1 site in 1 country56 target enrollmentOctober 1, 2006
ConditionsObesity

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Obesity
Sponsor
Oregon Health and Science University
Enrollment
56
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2006
End Date
July 1, 2015
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jonathan Purnell

Principal Investigator

Oregon Health and Science University

Eligibility 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.

Outcomes

Primary Outcomes

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

Study Sites (1)

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