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Study of Effects From Gastric Bypass Weight Loss on Brain Tissue

NCT00357344 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2017-07-02

No results posted yet for this study

Summary

This study will evaluate how large, intentional weight reduction affects the human brain and possible ways to reverse the changes associated with excess body weight. Subtle changes in some brain regions occur in people who are overweight. Such changes may involve the regulation of eating behavior, though it is not clear whether the changes were present before weight gain or are a consequence. Magnetic resonance imaging (MRI) will be used to study local structures of the brain.

Patients ages 18 to 45 who are undergoing gastric bypass surgery and who are not pregnant or breastfeeding may be eligible for this study. A study group of lean participants will serve as controls. Patients will visit the Phoenix Indian Medical Center for about 3 days at a time for tests. They will have a medical examination, electrocardiogram, and tests of blood and urine. Questionnaires they will complete involve patients' moods and possible influence on eating behaviors, as well as food preferences. A taste test, smell test, and assessment of decision-making processes will be conducted. An oral glucose tolerance test involves a needle placed intravenously (IV) in the arm, for drawing blood after patients drink a sugar solution. The test takes about 3-1/2 hours, with six blood samples taken (about 2 tablespoons total). A meal test also includes use of an IV line. After patients consume a liquid meal, blood will be collected to analyze levels of blood sugar and hormones. For the DEXA scan, which measures body composition, patients will lie still while low-dose X-rays are used for 5 to 10 minutes. Urine will be collected for 1 whole day, to measure cortisol, a hormone. The MRI scan uses a strong magnetic field to obtain images of body organs and tissues. Patients having any metal in the body that may interfere with the scanning machine should not have this test. For the MRI procedure, patients will lie on a table that slides into the enclosed tunnel of the scanner and be asked to lie still. Patients will be able to communicate with the MRI staff at all times during the scan, and they may ask to be removed from the machine at any time.

Conditions

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-24
Completion
2008-10-03

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00357344 on ClinicalTrials.gov