Seeking Volunteers for Clinical Trials
Many of the professionals at St. Luke’s and Roosevelt Hospitals are involved in cutting-edge research. This presents opportunities for people to volunteer and contribute to the advancement of medical science. Some of our ongoing clinical investigations are listed below.
Study name: Effect of Sleep Reduction on Daily Energy Expenditure, Thermic Effects of Food and Substrate Oxidation in Women
(IRB #11-072)
Purpose of study: This two-phase inpatient study will examine the link between sleep duration and energy expenditure in a group of healthy females.
Principal investigator: Marie-Pierre St-Onge, PhD
Summary: There is some research that suggests that there is a link between sleep duration and the rate at which your body uses fat and carbohydrates as sources of energy. This study will investigate how sleep duration may have an impact on the amount of energy your body burns in a day and after eating a meal. Participants in this study will receive compensation up to $450 for their time.
Eligibility criteria: We are seeking healthy females with average body weight. Eligible subjects must be between 21 and 25 years old, have a body mass index between 22 and 29 and must regularly sleep between 7 and 8.5 hours at night. Participants must be willing to stay at the hospital for two separate periods of three consecutive days.
Study site: St. Luke’s Hospital, 1111 Amsterdam Avenue at 114th Street, New York, NY 10025
Contact: For more information, please contact 212-523-1602 or slrsleepstudy@gmail.com with basic information (age, height and weight).
Study name: Fuel Utilization, Diet Composition and Exercise in African-American Women
(IRB #08-144)
Purpose of study: This study is designed to see if a 14-week, high-intensity interval training (HIIT) exercise program will improve aerobic endurance capacity, insulin sensitivity and post-absorptive fat oxidation in overweight and obese, sedentary, pre-menopausal, non-diabetic African-American women.
Principal investigator: Jeanine Albu, MD
Summary: The study’s screening process consists of two outpatient visits. On the first visit, we will test participants for diabetes and conduct a physical exam and EKG. During the second visit, we will measure the amount of calories each woman needs to consume daily as well as each woman’s base fitness level.
The study will also include two inpatient visits, one at beginning of the investigation and the other towards the end. During these visits, we will measure each woman’s caloric burn for 23 hours. This will be followed by imaging exams to specifically see the body composition of each woman. At the end of each inpatient visit, we will measure each participant’s insulin sensitivity.
During the trial, women will be randomly selected to go into either the HIIT group or the control group. The HIIT group members will come to our research center to train three times a week for 30 minutes. Women in the control group will come to the center once a week for their weight to be measured and to periodically meet with a dietician.
Participants will receive compensation of up to $1,000 for their time.
Eligibility criteria: Eligible subjects must be:
• African-American females (All four grandparents need to be African-American as well)
• Between the ages of 20 and 40
• Overweight to obese
• Not taking any medications (including oral contraceptives)
Study site: New York Obesity Nutrition Research Center, St. Luke's Hospital, 1111 Amsterdam Avenue at 114th Street, New York, NY 10025
Contact: For more information, please call 212-523-4187.
Study name: Diabetes after Weight Loss Surgery
(IRB# 03-108)
Purpose of study: This study analyzes the role of gut peptides -- small proteins that play a role in stimulating insulin during meals -- on insulin secretion, insulin sensitivity and blood glucose levels in individuals with diabetes, before and after surgical weight loss by gastric banding.
Principal investigator: Blandine Laferrère, MD
Summary: Participants will be examined during four study periods: before gastric banding surgery, then one month after surgery, and then one year and two years after surgery. During each study period, participants will make three separate visits in the morning to the research center for various glucose challenge tests and body composition measurements. These visits will last for about four hours. Partial compensation is provided to participants at the end of each study period. Total compensation for completing the two-year study is up to $1,950.
Eligibility criteria: Potential subjects are patients with obesity and diabetes who have chosen to have gastric banding surgery and have been approved by their surgeon to have gastric banding. Subjects must have a BMI above 35 kg/m2. They must also have health insurance coverage for routine medical and surgical care.
Study site location: New York Obesity Nutrition Research Center, St. Luke’s Hospital, 1111 Amsterdam Avenue at 114th Street, New York, NY 10025
Contact information: For more information, please contact Toni Colarusso at TColarus@chpnet.org or 212-523-3581.
Study name: Stress and Neuroimaging in Binge Eating Disorder (IRB #06-163)
Purpose of study: This study will investigate the biological basis of binge eating disorder, a common malady among overweight individuals.
Principal investigator: Allan Geliebter, PhD
Summary: This study will include five visits. During the first visit, the research team will take body composition measurements of the volunteers, administer questionnaires and conduct personal interviews. On the second visit, volunteers will undergo a physical exam. The third visit involves picking up a liquid meal to be consumed at home. During the last two visits, participants will be given stress tests (cold and warm water tasks) and have their blood pressure examined. A saliva sample will be collected for cortisol testing and a functional magnetic resonance imaging (fMRI) scan will be performed. In addition, volunteers will be given a buffet meal. Compensation is up to $350.
Eligibility criteria: We are seeking healthy, medication-free men and women who are either normal weight or overweight. Volunteers should be between the ages of 18 and 65.
Study site: The first three visits will take place at St. Luke’s Hospital, 1111 Amsterdam at 114th Street, New York, NY 10025. The two test days will take place at the New York State Psychiatric Institute at 1051 Riverside Drive, New York, NY 10032.
Contact: For more information, please call 646-543-3674 or e-mail apphormonefmri@gmail.com.
Study name: Brain Activation to Food Stimuli in Adolescents (IRB #10-052)
Purpose of study: This study will help us understand influences on appetite, eating and weight.
Principal investigator: Susan Carnell, PhD
Summary: We are assessing brain activity, genes and hormones in order to gain a better understanding of biological processes affecting appetite, eating and obesity. This study includes two visits. The first focuses on both adolescents and their biological mothers and includes an interview and body composition measurements. The second visit focuses only on the adolescents and includes the consumption of liquid and buffet meals, a blood draw for gene and hormone information and a functional magnetic resonance imaging (fMRI) scan. Adolescents should be accompanied by their parent or legal guardian. Compensation is up to $250.
Eligibility criteria: We are seeking healthy, normal weight and overweight boys and girls for this study. Volunteers should be medication-free and between the ages of 14 and 18.
Study site: The first visit will take place at St. Luke’s Hospital, 1111 Amsterdam at 114th Street, New York, NY 10025. The second visit will take place at the New York State Psychiatric Institute at 1051 Riverside Drive, New York, NY 10032.
Contact: For more information, please call 646-543-2365 or e-mail adolescent.brain@gmail.com.
Study name: Functional Brain Imaging and Appetite-Related Hormones Pre- and Post-Obesity Surgery (IRB #09-101)
Purpose of study: This study will compare hormone and brain imaging changes following weight loss from bariatric surgery or restrictive dieting.
Principal investigator: Allan Geliebter, PhD
Summary: The research team will study volunteers with gastric surgery or those that receive a formula diet. Evaluation with MRI and blood test will be done before and after weight loss. One group will receive bariatric surgery and the other will take part in a weight-loss program based on an all-liquid diet. Qualified candidates will complete an initial consultation and three assessments prior to the intervention, 3 months and 18 months after the intervention. These assessments will include brain scans and hormone measurements. Eligible participants will receive up to $800 in compensation as well as reimbursement for transportation.
Eligibility criteria: We are seeking men and women with obesity who are between the ages of 18 and 65, with a body mass index between 40 and 50.
Study site: The hormone measurements and weight-loss program will take place at St. Luke’s Hospital, 1111 Amsterdam at 114th Street, New York, NY 10025. The brain scans will be performed at the Functional MRI Research Center, Columbia University Medical Center, 630 West 168th Street, New York, NY 10032.
Contact: For more information, please call 212-523-1713 or e-mail bariatric.fmri@gmail.com.