Seeking Volunteers for Clinical Trials

Many of the professionals at Mount Sinai Health System Hospital Campuses 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: Vitamin D and Type 2 Diabetes (D2D)
(IRB# 163-13)

Purpose of study: This D2D study is sponsored by the National Institutes of Health (NIH). The object of the research is to determine if vitamin D delays or prevents the progression of pre-diabetes to diabetes in people who have pre-diabetes.
 
Principal investigator: Leonid Poretsky, MD (Director of the Gerald J. Friedman Diabetes Institute at Mount Sinai Beth Israel Medical and Chief of the Division of Endocrinology and Metabolism)

Summary: D2D is a multi-center, randomized, placebo-controlled, double-blinded study in which participants are asked to take either a single soft-gel of vitamin D3 or a matching placebo once daily for 4 years. After the initial screening, qualified participants will come to the clinic for 4 study visits during the first 6 months, and then once every 6 months for approximately 4 years. These visits will be scheduled in the mornings. Participants will be required to fast (no food or drink except water) overnight for 8 hours before each visit. All participants will receive personalized health information, information about the ways to monitor for the signs and symptoms of diabetes and educational materials on how to lower the risk of developing diabetes. A stipend is available to all participants who complete each of the study visits.

Eligibility criteria: Potential subjects are adults over the age of 30 who are at risk for diabetes. Participants should meet at least one of the following criteria: are overweight, have a parent or sibling with diabetes, had gestational diabetes and/or are willing to take a daily supplement. Persons with diagnosed diabetes, kidney stones or kidney disease are not eligible.

Study site location: Mount Sinai Beth Israel Medical Center, Endocrinology Department, Friedman Diabetes Institute, 317 East 17th Street, 8th Floor, New York, NY

Contact information: For more information, call Kamala (kmantha@chpnet.org) at 212-420-3569 or visit www.d2dstudy.org.

Please click to view the brochure and flyer.

__________________________________________________________________________________________________________________________________________________


Study name: Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (IRB#12-161)

Purpose of study: Most people with type 2 diabetes eventually need two drugs to control blood sugar levels. This GRADE study will determine which combination of two drugs is best for blood sugar control, has fewest side effects, and is the most beneficial for overall health.

Principal investigator: F. Xavier Pi-Sunyer, MD

Summary: Participants will be given one of four FDA-approved drugs to take in addition to metformin. Participants are asked to attend four to five inpatient visits per year at Mount Sinai St. Luke’s. Most visits will last approximately one hour; one yearly visit may take up to five hours. Patients will receive free diabetes medications, care, and education. Patients also receive a stipend of $50 per visit and are reimbursed for related travel expenses.

Eligibility criteria: Potential subjects are patients who are at least 30 years of age, who have been diagnosed with type 2 diabetes within the past five years, and who are currently being treated with the metformin drug exclusively. Subjects must have an HbA1c greater than 6.8%.

Study site location: Mount Sinai St. Luke’s, 1111 Amsterdam Avenue at 114th Street, Babcock Building, 10th Floor, New York, NY 10025

Contact information: For more information, call Pablo Villegas, MD (pvillegas@chpnet.org) at 212-523-4171 (English) or 212-523-3580 (Spanish).

__________________________________________________________________________________________________________________________________________________


Study Name: Treatment of Diabetes After Gastric Bypass Surgery with
Sitagliptin (IRB# 11-156)

Purpose of study:
This study will analyze the effect of sitagliptin (Januvia®), an FDA-approved medication, for the treatment of type 2 diabetes in patients who have had gastric bypass surgery.

Principal investigator: Blandine Laferrère, MD

Coinvestigator: James McGinty, MD; Scott Belsley, MD; Aastha Pal, MD;
Sinan Altiner, MD

Summary: This study will include four visits. Over a period of six to eight weeks, participants will come in to the research center for two half-day research visits and two one-hour research visits. Participants will take either sitagliptin (Januvia®) or a placebo pill for four to six weeks. The four visits completed at the research center are as follows:
    Day 1: Initial screening
    Day 2: A four-hour meal test with IV
    Day 3: Midway check-in appointment for questionnaires (about one hour)
    Day 4: A second four-hour meal test with IV

Participants can learn about their diabetes status, see whether the medication could be of any benefit to treat their diabetes, and get nutritional and diabetes education and materials. $300 in compensation will be given.

Eligibility criteria:
Potential participants will have had gastric bypass surgery at least one year ago, and will have been diagnosed with type 2 diabetes prior to their gastric bypass surgery. Participants must have a current Hba1c > 6.4% and/or fasting blood glucose (sugar) > 125 mg/dl, and should be able and willing to check glucose by finger sticks.

Study site: New York Obesity Nutrition Research Center, Mount Sinai St. Luke’s, 1111 Amsterdam Avenue at 114th Street, New York, NY 10025

Contact: Call Margaret Sala (msala@chpnet.org) at 212-523-3503 or Carolina Espinosa (cespinosa@chpnet.org) at 212-523-3581.

__________________________________________________________________________________________________________________________________________________


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, both before and after surgical weight loss by gastric banding.

Principal investigator: Blandine Laferrère, MD

Coinvestigators: James McGinty, MD; Ninan Koshy, MD; Eugenius Harvey, MD;
Scott Belsley, 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 morning visits to the research center for various glucose challenge tests and body composition measurements. Each visit will last approximately 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, Mount Sinai St. Luke’s, 1111 Amsterdam Avenue at 114th Street, New York, NY 10025

Contact information: For more information, call Carolina Espinosa (cespinosa@chpnet.org) at 212-523-3581 or Margaret Sala (msala@chpnet.org) at 212-523-3503.

__________________________________________________________________________________________________________________________________________________


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: Mount Sinai St. Luke’s, 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, Mount Sinai St. Luke's, 1111 Amsterdam Avenue at 114th Street, New York, NY 10025

Contact:
For more information, please call 212-523-4187.

__________________________________________________________________________________________________________________________________________________


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 Mount Sinai St. Luke’s, 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 Mount Sinai St. Luke’s, 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 Mount Sinai St. Luke’s, 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.