Study of High Blood Insulin Levels With Body Changes
University of Washington AIDS Clinical Trials Unit
There have been great improvements in the health and life-span of persons with HIV who are treated with potent anti-HIV therapies. However, there is increasing concern about metabolic changes. The metabolic changes that have been seen include problems with the way the body handles sugar (high blood insulin levels, impaired glucose tolerance, high blood sugar), high levels of fat in the blood, and changes in body shape. Shape changes include increased fat around the waist. These changes may increase the risk of future cardiovascular problems and may affect people's willingness to take anti-HIV drugs. The causes of these metabolic and body changes are not yet known. They were initially thought to be caused by protease inhibitors (PIs), but these abnormalities have also been seen in people who have not been treated with PIs. There is increasing evidence to suggest more than one cause. It is important to determine the cause and also important to find effective treatments for metabolic and body shape changes.
The purpose of this study is to look at the safety and efficacy of two drugs that are currently used for treating diabetes as treatment for the fat around the waist and metabolic changes involving sugar. The two drugs are metformin and rosiglitazone. The study will test their effects when used alone and together.
Study participation will last about 8 months. Participants must have elevated blood insulin levels and increased body fat around the waist. For the first 4 months of the study, all subjects will receive metformin, rosiglitazone, both, or neither. During the second 4 months, all participants will receive both drugs. Subjects will have clinic visits every 2 to 4 weeks. The study visits will include brief physical exams, blood draws, and body measurements. Participants will receive CT and DEXA scans (special x-rays that measure body shape and body fat) at entry and at weeks 16 and 32. Potential participants do not need to know if they have a high insulin level, but they may be concerned about fat increases in the abdomen. Subjects will receive $20 for each study visit and $25 for each CT and DEXA scan. For more information on this study contact Alyssa Spingola or Lori Cray at 206.731.3293.
This article was provided by Seattle Treatment Education Project. It is a part of the publication STEP Perspective.