Study of Effects From Gastric Bypass Weight Loss on Brain Tissue

Completed

Conditions studied: Weight Loss

In brief

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.

Key facts

Study ID

NCT00357344

Run by

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

People needed

80

Starts

2006-05-24

Expected to finish

2008-10-03

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• History or clinical manifestation of:
• Current smoking
• Type 2 diabetes (according to the World Health Organization diagnostic criteria (63))
• Endocrine disorders, such as Cushing's disease, pituitary disorders, and hypo- and hyperthyroidism
• Pulmonary disorders, including chronic obstructive pulmonary disease that would limit ability to follow the protocol (investigator judgment) and obstructive sleep apnea syndrome; only subjects with mild or exercise-induced asthma on no medications or on beta-adrenergic agonists only (such as albuterol) will be allowed to enter the study
• Cardiovascular diseases, including coronary heart disease, heart failure, arrhythmias, and peripheral artery disease
• Hypertension, as diagnosed and treated by an outside physician or by sitting blood pressure measurement, using an appropriate cuff, higher than 140/90 mmHg on two or more occasions
• Gastrointestinal disease, including inflammatory bowel diseases (e.g. Crohn's disease and ulcerative colitis), malabsorption syndromes (e.g. celiac disease), gastric ulcer (active); only subjects with gastro-esophageal reflux will be allowed to enter the study
• Liver disease, including cirrhosis, active hepatitis B or C, and AST or ALT greater than or equal to 3x normal
• Renal disease, as defined by serum creatinine concentrations greater than or equal to 1.5 mg/dl and/or proteinuria greater than 300 mg/day (200 microgram/min)
• Central nervous system disease, including previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders
• Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer)
• Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators
• Personal and/or family history of major psychiatric disorders based upon the DSM-IV (64), including depression, schizophrenia, and psychosis, which may affect brain tissue composition independent of obesity.
• Medications acting on the central nervous system and steroidal drugs within 2 months of the baseline study. Non-steroidal anti-inflammatory drugs (NSAID), proton pump inhibitors, and anti-acids will be allowed but discontinued 3 or more days before the admission.
• Alcohol and/or drug abuse (more than 3 drinks per day and use of drugs, such as amphetamines, cocaine, heroin, or marijuana).
• Contra-indications for MRI, including pacemakers and/or ferromagnetic implants and claustrophobia.
• Pregnancy or lactation.
• All subjects will be fully informed of the aim, nature, and risks of the study prior to giving written informed consent.

Where it is running

• NIDDK, Phoenix — Phoenix, Arizona, United States
• Good Samaritan Regional Medical Center — Phoenix, Arizona, United States
• Mayo Clinic — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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