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Completed

NCT Number: NCT00686608

Hypothalamic Functional Magnetic Resonance Imaging (fMRI) Response to Nutrients

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glucose

Dietary Supplement

0.3mg/kg of glucose

Fructose

Dietary Supplement

fructose IV bolus

Saline

Dietary Supplement

IV saline

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Hypothalamic fMRI Response to Nutrients

Important dates

Study start
2006
Primary completion
2012
Study completion
2015
First posted
May 30, 2008
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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