Hello current and future volunteers! We hope the “Participating in NIH Research” newsletter will be interesting and helpful for all of you. This publication provides insight into the exciting world of the National Institutes of Health (NIH), offers lots of good medical information, and also profiles some of the NIH studies that are currently enrolling patients.

The “Participating in NIH Research” newsletter includes information about both healthy volunteer and patient studies. No matter if you have a pre-existing health condition or if you are interested in becoming a healthy volunteer, this newsletter is for you!

Children and Allergies
Study number: 05-I-0084
Does your child have allergies? Physicians at the National Institute of Allergy and Infectious Diseases (NIAID) are conducting a research study to learn more about allergies. This study will evaluate children with different allergies in order to learn more about their diseases and to gain information that may be useful in developing new treatments. Standard care for allergic diseases will be provided at no cost to the patient.

Blood Count Study
Study number: 03-DK-0168
Your blood may tell us a story! It may tell us a real story! At NIH, we want to know why people have different blood counts. Please call us if you are a healthy adult and are of an African-American, African-Caribbean, or African ancestry and would like to participate in a blood count study.

Child and Teenage Obesity
Study numbers: 00-CH-0134 and 98-CH-0111
Physicians at NIH are looking for obese children and adolescents for a weight loss study. The study is testing how effective the following medications are in weight loss: Metformin in children ages 6–11 and Orlistat in adolescents ages 12–17. Both medications will be tested against a placebo (a pill with no medicine in it), but all volunteers will have an opportunity to take the study medication. NIH provides all study-related testing, evaluation, study medication, and weight-loss education at no charge to the patient or family.

Eating Behavior in Children
Study number: 04-CH-0050
The National Institute of Child Health and Human Development seeks children ages 8-17 years to participate in a research study of eating habits. Participation involves eating a meal at the NIH in Bethesda, Maryland on three separate weekdays and a blood draw. Children who qualify to participate in this study will be compensated for their time and inconvenience.

Study for Parents and Healthy Adolescents
Study number: 98-AA-0056
Doctors at the National Institutes of Health invite you and your adolescent child to participate in a brain scan study. The study involves 2 outpatient visits. Procedures include a physical exam and brain scan for the adolescent and a psychiatric screening interview and questionnaires for both the adolescent and parent.

Your adolescent may be eligible to take part if: he or she is age 12–17 and in good physical health. Your adolescent may not be eligible to take part if he or she has any neurological disorder, is taking any psychiatric medication (ie, Prozac), or he or she has any metal in body such as braces and implants. Compensation is provided for both the adolescent and parent.

Turner Syndrome Study
Study number: 00-CH-0219
We are conducting a natural history study to learn more about Turner Syndrome. Study related comprehensive evaluation at no cost to the participant (including cardiac evaluation with MRI, evaluation of bone density, evaluation of risk for diabetes, and evaluation of ovarian function). This study is for females age 10 through 70 with a karyotype showing evidence of Turner Syndrome.

Swallowing Studies
Study numbers: 06-N-0212 and 06-N-0120
Many people with brain injury, stroke, or other neurological disorder experience difficulty in swallowing, a condition known as “dysphagia.” National Institute of Neurological Disorders and Stroke (NINDS) researchers are conducting two different experimental studies for qualified participants that may improve swallowing. Both studies involve new methods of stimulation during swallowing training. Individuals may either stay at no cost as an inpatient at the National Institutes of Health, or come as an outpatient (approximately 16 visits for study 06-N-0212 and 18 visits for 06-N-0120).

The Study of Neurofibroma Growth in Adults with NF1
Study numbers: 06-HG-0134 and 05-HG-0152
We invite you to join a study of neurofibromatosis type 1 (NF1) in adults. We are trying to answer a simple question: How fast (or how slow) do skin neurofibromas grow? By answering this question, we hope to lay the groundwork for future trials of new drugs to control the growth of neurofibromas. We also hope to find genes that control the growth of neurofibromas in NF1.

With this study, we are trying to learn how fast or slow neurofibromas grow, and how often they appear. We also are looking for the genes that control the growth rate of the tumors. The results of this study may help us design future trials to test new drugs to treat the tumors. If we can find genes that control the growth rate of the tumors, we hope to use those genes to predict the approximate number of tumors a person with NF1 might have.

Leg Pain Study (Leg Claudication)
Study number: 04-H-0143
The National Institutes of Health invites you to participate in a clinical study for intermittent claudication, muscular leg pain during walking due to poor arterial circulation. All study-related tests or treatment are provided at no cost.

Search for more clinical trials at http://clinicalstudies.info.nih.gov. Please type the word “Healthy” for a full listing of NIH Healthy Volunteer opportunities. You can also search by individual keywords to find specific NIH patient studies.

All NIH studies are conducted in Bethesda, MD just 9 miles north of Washington DC and conveniently located on the metro’s red line. Compensation is provided for the healthy volunteer studies featured above.

	Dr. Monica C. Skarulis is a physician and senior clinical investigator with special training in endocrinology, diabetes, and metabolism. She is the acting director of the NIH Intramural Obesity Research Initiative and chief of the clinical endocrine section of the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Skarulis and colleagues are examining the physiological, hormonal, and behavioral traits that lead to obesity, weight loss, or relapse. Q: What is the primary focus of your clinical trials? A: The focus of our work here on the NIH metabolic clinical research unit is to look at the functional and pathological differences in different people’s metabolism. Previously, many doctors in many NIH institutes were conducting obesity research separately. However, since this unit opened, we have been able to combine our efforts in many different fields including endocrinology, cardiology, and even cancer research to work together and study this disease. Q: How did your team become involved with the new metabolic research unit when it opened in March 2007? A: Obesity is a very real threat to a majority of our population. Overall, 67% of adult Americans are obese and 14% of adolescents are obese or at risk of becoming obese. When the Department of Health and Human Services (HHS) recommended the need for further research into obesity, NIH director Dr. Zerhouni made it possible for us to open this unit and set up a roadmap for studying obesity. Q: How long have you been working with healthy volunteers in your studies? A: We have been working with healthy volunteers for many years in our studies. It is important to realize that obesity is a curable disease and we need these volunteers to help us understand the biological factors that contribute to weight loss and weight gain. Until we learn the baseline “healthy” information, we can’t develop new ways to intervene. So the healthy volunteers help make that possible. Q: What kinds of clinical trials do you conduct for your research? A: Our unit has integrated both holistic (natural and organic) therapies and interventional therapies into many different kinds of clinical research studies. We conduct natural history and characterization studies which help us understand the baseline information about obesity. And we also conduct studies such as a type 2 diabetes study, a sleep and weight loss study, a diet-induced weight loss study, and many others which target specific conditions that are affected by obesity. Q: What is your motivation regarding research? A: The patients that we work with in these studies are a great group of people. Because this unit provides a multi-faceted and holistic approach to treating this disease, we want the patients to have a pleasant experience here and actually learn to understand obesity. So we are happy when patients say that they’ve learned a lot about their health and their bodies because it is the individual patients that are our priority. Q: Where do you see your research progressing in the next 10 years? A: In just a few years we want to be in the forefront of obesity research. Right now we are trying to develop the most advanced technology to study obesity and plan to implement the knowledge we gain in order to advance this field. Q: Because of your work with metabolism and obesity, what have you learned is the best way to stay healthy? A: There are only four words to remember for staying healthy: “Eat Right and Exercise.” That’s it. You need to always make sure that your intake (the amount of food you eat) is less than your output (the energy you expend), or you are going to gain weight. So everyday, just make sure that you exercise and eat right.