Protocol Number: 07-DK-0115
This study includes patients 12 to 20 years of age with T2DM who are overweight and who were diagnosed within 1 year of enrolling in the study. Healthy individuals of normal weight or who are overweight are also eligible. Candidates are screened with a medical history, physical examination and laboratory tests. Participants with T2DM are assigned to one of two groups. Group 1 takes an anti-diabetes medicine called metformin and follows a diet prescribed by a study staff dietitian for 2 weeks. Group 2 takes metformin, follows the prescribed diet, and receives insulin through a pump under the skin and diazoxide by mouth for 2 weeks. All patients are hospitalized for this 2-week period. During this time, they have the following tests: -Frequent blood sugar checks. -Oral glucose tolerance test (routine diabetes test in which blood samples are drawn before and several times after the subject drinks a sugary solution). -Arginine stimulation to test the response of the body to arginine, a normal ingredient of food that stimulates the release of insulin. Two catheters are placed into veins in the arms, one to administer a liquid containing arginine, the other to draw the blood samples. -Ultrasound of the blood vessels in the neck to check for hardening of the arteries. -Metabolism test to measure the amount of oxygen used during rest. The subject breathes normally during rest while wearing a canopy over his or her head for about 20 minutes. -MRI scans of the abdomen to examine the amount of fat in the belly (at the beginning and end of the study) -DEXA scan to determine percent body fat. -Tests to explore quality of life and feelings about health, work or school, friends and family. -Exercise testing on a treadmill or stationary bicycle. -Genetic studies for information on diabetes and obesity. Normal volunteers have blood draws, oral glucose tolerance testing, MRI scan, DEXA scan, psychological testing, exercise testing, and genetic testing.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/16/2008
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