Nutrition Management


Nutrition and Weight Management Research Center


Industry-Sponsored Research Studies
please call (617) 638-3175 for more information.

1. Pfizer
A 14 month, randomized, double blind, placebo controlled phase 3 study to evaluate the long term efficacy and safety of CP 945,598 in prevention of weight regain in obese subjects.

The purpose of this study is to evaluate the safety and effectiveness of CP 945,598, an investigational drug, as compared to placebo on weight regain after weight loss in obese subjects when taken for 12 months. For the first 8 weeks of this study, subjects will be on a Low Calorie Diet (LCD) of 800 1000 calories per day. If you lose 3% of your initial body weight, you will continue following a low calorie diet for 12 months, along with study drug or placebo. You will have regular visits with a dietitian (someone who specializes in nutrition and counseling of overweight people) and will be given a diet, exercise guidebook and a pedometer. The dietitian will share advice on how to change behavior to lose weight, how to reduce the calories in the diet and how to become more physically active.

2. Orexigen NB-303
This study will try to find out if the combination of topiramate and bupropion will help people lose weight. This drug combination, or placebo, will be paired with diet and exercise advice from regular visits with a dietitian.

3. Orexigen ZB-201(Closed to Enrollment)
A Dose Parallel, Randomized, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Multiple Regimens of the Combination of Zonisamide CR plus Bupropion SR in the Treatment of Subjects with Uncomplicated Obesity

This study will try to find out if the combination of zonisamide CR and bupropion SR will help people lose weight over a period of 24 and 48 weeks. It will also try to find out if greater weight loss with fewer side effects will happen by changing the doses of each study drug in the combination; increasing the doses more slowly; and using a controlled release form of zonisamide.

The study will measure blood pressure, pulse, waist circumference, measure blood sugar, insulin, cholesterol, triglycerides, hs CRP (measures inflammation), ask about your mood and depression and anxiety, look at your ability to process information, ask about your quality of life, ask about your sleep.

4. Lilly H80-US-GWBM (Closed to Enrollment)
Effect on Weight Loss of Exenatide Versus Placebo in Subjects with Type 2 Diabetes Participating in a Lifestyle Modification Program.

Participants must be taking one or more of the following medications: Glucophage (metformin), Amaryl (glimepiride), Glucotrol (glipizide) and not be taking insulin. If you are able to participate in the study, you will receive study-related medical exams and lab work, glucose monitor and supplies, reimbursement for diabetes medications you currently take, compensation for travel, dietary and exercise counseling, and a 6-month gym membership.

5.VICTORIA(Closed to Enrollment)
A randomized, double blind, two-arm placebo controlled, 12 Month study of the effects of rimonabant 20mg once daily on the amount and the activity of visceral fat in abdominally obese patients with metabolic syndrome. The study is designed to assess the safety and effectiveness of an investigational drug called rimonabant compared to placebo (sugar pill) in subjects who have abdominal obesity (meaning a large belly with waist measurement larger than 40 inches in men or larger than 35 inches in women) plus other risk factors of atherosclerosis (hardening of the arteries).

6.GlaxoSmithKline
A Once-Daily Dose-Ranging Study of GSK189075 Versus Placebo in the Treatment of Type 2 Diabetes Mellitus in Treatment-Naïve Subjects.

The sponsor of this research (GlaxoSmithKline) is developing a new drug, known as GSK189075, to help people with type 2 diabetes in lowering blood sugar levels. To participate in this 16-week study, you must have type 2 diabetes that is treated with diet and exercise, but not other medications (pills) or insulin. You will receive compensation for participating in the study.

Nutrition Research Studies
please contact Sherman.bigornia@bmc.org or call (617) 414-6284 for more information.

1. Use of MCT Oil for Enhancement of Weight Loss and Glycemic Control in Obese Diabetic Patients.

The purpose of this research study is to see if a low calorie diet using medium chain triglycerides (like coconut oil) and liquid meal replacements will improve weight loss, improve blood sugar control, and reduce fatty acid levels in obese, diabetic patients, as compared to a low calorie diet using long chain fatty acids (like corn oil) and liquid meal replacements. To participate, you must have diabetes and take Metformin to reduce your blood sugar or have a fasting blood suger greater than 100 mg/dL. You will receive diet instructions from a registered dietitian on a weekly basis for 12 weeks.

2. Alterations in Fat Cell-Derived Adipocytokine Expression Before and After Weight Loss. The purpose of this study is to explore the way that fat tissue influences metabolism before and after weight loss in overweight and obese patients. To participate, you must be a patient in the Nutrition and Weight Management Center, seeking weight loss. There will be 8 study visits. During 4 of the visits we will conduct an abdominal fat biopsy (fat will be withdrawn from just beneath the skin), a DEXA scan to measure body composition, and draw fasting blood work. , At the other 4 visits we will remove the stitches from the fat biopsies.

3. Alterations in Fat Cell-Derived Adipokine Expression Between Subcutaneous, Omental, and Mesenteric Fat Depots. The purpose of this study is to compare the amount of fat hormones express between three different types of fat tissue: omental, mesenteric, and subcutaneous fat. To participate, you must be pre-approved for gastric bypass surgery at Boston University Medical Center. This study includes 1 visit that will occur sometime before your surgery where fasting blood will be drawn. During the time of your gastric bypass surgery the surgeon will obtain the appropriate fat tissue biopsies.

4. Imaging the Vascular Consequences if Lipid Deposition. The purpose of this study is to measure the amount of fat in the heart and liver and how the distribution of fat changes with weight loss. To participate you must have metabolic syndrome and be a patient in the Nutrition and Weight Management Center seeking weight loss. Metabolic syndrome is defined as having 3 of 5 criteria. These are: high triglycerides, low HDL, high blood sugar, high blood pressure, and a waist circumference greater than 35 inches for woman or 40 for men. Two visits will be conducted with 1 year in between each visit. At each visit an MRI (Magnetic Resonance Imaging) will be conducted and blood drawn.

5. Effect of Nutrition and Weight Modification on Endothelial Function. The purpose of this study is to determine the effects of weight loss on your cardiovascular health. To participate you must be a patient of the Nutrition and Weight Management Center seeking weight loss. We will conduct 4-5 visits over a 1 year period. At each visit blood will be drawn and an ultrasound of the artery in your bicep will be conducted.

Surgical Research Studies
please contact Ashley.Bourland@bmc.org or call (617) 638-5906 for more information.

1. Assessment of Bariatric Surgery (ABS) Study
The purpose of this study is to better understand how patients who are thinking about having weight loss surgery feel about their health and weight before and after their weight loss surgery. To participate, you must be a patient of the Nutrition and Weight Management Center and be thinking about having weight loss surgery in the future. This study involves up to 4 telephone surveys in the first year and one survey a year for up to three years.