University of Vermont Clinical Research Center
Current CRC Protocols
830 Dr. Naomi K. Fukagawa
DIABETES IS ON THE RISE……
What can YOU do to help better understand the disease?
Everyone has heard that there is an epidemic of diabetes mellitus (DM) and obesity in the U.S. Older individuals are at high risk for developing DM and many of the complications associated with the disease, such as heart disease, kidney failure and impaired sensation. All of this contributes to increased disability and increased health care costs. An individual’s antioxidant status may influence his/her susceptibility to the complications associated with DM. We are investigating how a person makes glutathione (GSH), an antioxidant that your body makes and which makes up the largest pool of antioxidants in your body. Antioxidants help to detoxify free radicals, and low levels of GSH are associated with advancing age as well as DM. This investigation involves 3 studies which will be conducted in the General Clinical Research Center (GCRC) at the University of Vermont and Fletcher Allen Healthcare. We will determine your ability to make GSH and whether a nutritional supplement could influence your responses. Participation in this investigation will involve eating a standardized diet provided by the GCRC for 4 days prior to each study. In addition, your metabolic rate, body composition and general health will be assessed. You will be compensated for your time and participation.
We are recruiting healthy, nondiabetic men and women over 60 years of age and diabetic men and women over 60 years of age whose diabetes is managed by diet alone or with medications. If you are interested, please call 656-4403 and leave your name and contact number. You may also email Dr. Fukagawa at Naomi.Fukagawa@uvm.edu.
858 Dr. Alexandra Potter, PhD
Effect of Acute Nicotine on Motor Function in ADHD
PURPOSE: To determine the effects of acute nicotine and methylphenidate (Ritalin) on motor function in young adults with ADHD.
WHO: 18-25 year old non-smokers, who have ADHD or have been told they may have ADHD
WHAT: 1 Screening visit and 3 study visits (5 hours each). At each study visits subjects will be randomly assigned either a nicotine patch, methylphenidate, or a placebo. After drug administration subjects will complete a series of tasks to test their fine and gross motor functions.
COMPENSATION: Up to $150
POSSIBLE SIDE EFFECTS: Nicotine may cause sleep disturbance, nausea, localized skin irritation, respiratory symptoms, increased heart rate and/or blood pressure (symptoms subside after removal of the patch). Methylphenidate (Ritalin) may cause nervousness, trouble sleeping, nausea, dizziness, and/or headache (resolve within 4 hours)
For more information about any of our studies, contact Eva Doane at 847-5444
965 Dr. Naomi Fukagawa
CAN NUTRITIONAL SUPPLEMENTS ENHANCE YOUR EXERCISE PERFORMANCE?
Investigators at the University of Vermont and Fletcher Allen Health Care are conducting a research study to determine whether 4 weeks of supplementation with specific amino acids (building blocks of protein) will improve your exercise performance.
Volunteers must be between 18-35 years of age, in good health and physically active but not engaged in competitive sports or specific physical performance training. Study includes body composition analysis, nutritional assessment, and exercise testing. Participants will be paid $350 for completing the study.
INTERESTED IN LEARNING MORE???
Please contact Naomi Fukagawa at (802) 656-4403 or via email Naomi.Fukagawa@uvm.edu.
1001 Dr. Lawrence Kien
Research Subjects Wanted
Healthy males & females (18-40 yr.) with both overweight and lean body types for an 8 wk nutritional study of the effects of type of dietary fat on body fat balance, insulin activity, and brain function. Women cannot be pregnant during the study.
Eligible subjects will receive:
- Free clinical examination, blood lipid & sugar testing, and exercise testing
- $1000 for time and expenses
- Will take place at University of Vermont’s College of Medicine, General Clinical Research Center (GCRC).
- Will consist of 4 separate feeding periods during which the subject will be able to eat only food provided by the study personnel: 7-day low fat control diet; 21-d moderately high fat experimental diet (saturated fat or monounsaturated fat); then a repeat of the control diet and the alternative experimental diet (using solid foods with all meals provided by the GCRC). During this period, food will be adjusted to prevent or greatly minimize weight gain or loss. Desserts and beverages (other than water) and snacks as well as all other food will be not be allowed except for the balanced diet provided by study personnel.
- Will require fMRI scans during each of the experimental diets and blood tests at the end of the first control diet and at the end of each of the experimental diets
- There will be measurements of physical activity continuously during the study and body fat will be measured at the beginning and at the end of each experimental diet
- Please contact Dave Ebenstein, (firstname.lastname@example.org) or 802-656-9093. Email is preferred
- And provide us with your weight, height and birth date
1018 Dr. Ira Bernstein
We are conducting a study that seeks to understand the relationship between a woman’s health and physiology prior to pregnancy and the risk of developing preeclampsia during pregnancy. We are currently recruiting women who are planning to become pregnant within the next year and who might be at risk for the development of preeclampsia during pregnancy. If you are you thinking about becoming pregnant soon and fit into one of the following categories we would like to speak with you about possible participation The groups include 1) If you are between 18 and 40 years old and you are planning to conceive your first child, 2) If you have Type 1 diabetes, or have a personal or family history of hypertension, or 3) If you have had preeclampsia in a prior pregnancy. Preeclampsia is a disease of pregnancy, associated with high blood pressure as well as the appearance of protein in the urine in pregnant women. It can be dangerous to both mother and baby. In this study, we will be looking for ways to predict whether a woman is at increased risk for preeclampsia and gain insights into improved ways to both prevent and treat it.
If you choose to participate, you will undergo testing on 3 occasions, one prior to pregnancy and 2 during your pregnancy, if you become pregnant. For each visit, you will be provided meals for 3 days prior to your appointment. During the initial visit, we will ensure you are not pregnant before allowing you to continue in the study. Using ultrasound and MRI, we will measure the way blood flows in your body. You will spend one night in the General Clinical Research Center (GCRC) at Fletcher Allen during each visit. We will provide you with ovulation detection kits to aid your timing in achieving conception. Financial compensation of up to $375 is provided.
If you are interested in participating, or would like to know more, please call (802) 656-0309 and leave your name and phone number. You can also email Carole McBride at Carole.Mcbride@uvm.edu
1023 Dr. Rup Tandan
Clinical Trial of High Fat/High Calorie Diet versus Optimal Nutrition in Amyotrophic Lateral Sclerosis
What is the purpose of the research study?
This study is designed to examine the safety and tolerability of high fat and high calorie diets in people with ALS.
People with ALS lose weight rapidly because they burn more calories than healthy people. While patients with ALS are told to maintain their weight, the amount of calories they need and the type of calories that would be best for them has not been studied.
Why calories from fat?
We are focusing on fat because burning fat produces less carbon dioxide than burning carbohydrates and therefore might be better for people with ALS who are having breathing problems. Two studies of a mouse model of ALS showed that feeding them a diet high in fat significantly increased their lifespan.
What will happen during the study?
If you choose to participate in this study, you will need to make 5 visits to the study site. At these visits, a variety of procedures will be performed, including:
- Take your medical history
- Examine you, take your vital signs including height and weight and test your breathing
- Measure exactly how many calories you are burning and your percent body fat
You will then be given a special diet to take through your feeding tube for the whole study.
How do I qualify for this study?
Participants in this study need:
- A diagnosis of ALS
- You must be 18 years of age or older
- You must have a g‐tube or j‐tube, and be tolerating your current tube feed prescription.
- You cannot be on a ventilator or require non‐invasive ventilation (BIPAP) for more than 10 hours/day.
How long does the study take?
The study will take about 5 months.
What are some of the risks of the study?
Common side effects found with the tube feeds used in this study, and with most tube feed include: Diarrhea, Nausea, Vomiting, Abdominal Fullness and Cramping, Belching, Flatulence (gas), Heartburn and Weight Gain.
What are the benefits of the study?
You will be contributing to knowledge about ALS, and future treatments for the disease.
If you are interested in participating in this trial, please contact the study coordinators, Colette Oesterle and Shannon Lucy at UVM at 802-656-3878. If you have any more questions, please visit our website: http://www.alsconsortium.org/
M09-064A – Dr. Alexandra Potter, PhD
13-65 year olds with ADHD are needed to participate in research studies investigating ADHD & the Brain. (ADHD diagnosis not required)
Studies include a 1 hour fMRI (brain scan).
Compensation ranges from $30-$50.
If you, or your child, are interested in finding out more, call Eva at 847-5444.
M09-064B - Dr. Alexandra Potter, PhD
Brain Function and ADHD – A study of the effects of nicotine and Ritalin.
18-25 year olds with ADHD are needed to participate in research looking at patterns of brain activation associated with nicotine and Ritalin.
Volunteers will complete three 6-hour study visits in which they will receive nicotine alone, Ritalin alone, or placebo. Study visits include a 1-hour fMRI (brain scan).
Compensation up to $300.
If you are interested in finding out more, call Eva at 847-5444.
M10-084 Dr. Alexandra Potter
How does your brain process social information?
The goal of this study is to determine how social information is processed differently from other types of information. We believe that acetylcholine, a naturally occurring chemical in the brain which is important in processing non-social information, may also be related to how social information is processed.
We are looking for 18-25 year olds who may have difficulty interpreting social cues or forming/maintaining relationships, to participate in research looking at patterns of brain activation associated with processing emotional information.
You may have difficulties interpreting and understanding social information if:
- You find it hard to make and maintain friendships
- You or a first degree relative have an autism spectrum disorder
- You or a first degree relative have symptoms of schizophrenia
- You misread social cues
Volunteers will complete two 4-hour study visits including a 1-hour fMRI (brain scan).
Compensation up to $175.00
If you are interested in finding out more, contact Eva at 847-5444 or ENDoane@uvm.edu
M12-142 Dr. Beth Kirkpatrick and the Vaccine Testing Center
Current Study 2012: Dengue Fever Vaccine study
This exciting research study aims to test the effectiveness and safety of an experimental vaccine for the prevention of dengue fever. This vaccine, but a different lot, has already been tested in another trial and was generally well-tolerated. This current research trial will evaluate a new lot of this vaccine, and the results will be compared with those of the previous trial.
The study has been designed for maximum volunteer safety and has been approved by the U.S. Food and Drug Administration (FDA), the UVM Institutional Review Board and the UVM Biosafety Committee.
Volunteers' responsibilities will be fully explained during the first visit. These include one screening visit, two dosing visits and 22 additional follow up outpatient visits. Volunteers will receive either the research vaccine or a placebo, and will be asked to keep a daily record of their temperatures over the first 16 days of the study.
Dengue fever is rare in this country but common in most tropical and subtropical regions of the world, where about 50-100 million cases have been reported per year. We hope that this research study will lead to a vaccine that will protect human populations against this viral infection.
Click on the following links for information about the disease, Dengue fever.
Vaccine Testing Center
University of Vermont, College of Medicine
phone: 656-0013 fax: 656-0881
Last modified October 24 2013 10:49 AM