Massachusetts

Beth Israel Deaconess Medical Center

General Clinical Research Center
Beth Israel Deaconess Medical Center, GZ-800
330 Brookline Avenue
Boston, MA 02115

Web site: http://www.research.bidmc.harvard.edu/gcrc

Grant No. M01 RR01032

Center Resources

Clinical Investigator Training Program: Two year, multidisciplinary training program for postdoctoral fellows. Cooperative venture with MIT/HST, Pfizer, and FDA. Majority of time spent on patient-oriented research project with strong didactic program addressing full range of topics important to clinical investigators. Graduates are eligible for Master of Science degree from Harvard Medical School.

Special Assays, Services, or Tests

Catecholamines–urine, plasma
Inulin–urine, serum
Measurement of markers of cardiovascular reactivity and endothelial dysfunction
Microelements in biological fluid using atomic absorption spectroscopy
Purification and determination of organic compounds, including free fatty acids, using HPLC and gas chromatography
Radioimmunoassays: Core lab offers various RIA, FIA, EIA, and chemiluminescent immunoassays

Special Resources, Instruments, or Services

Body composition analysis: bioelectrical impedance analysis, DEXA
Diode array spectrophotometer
Dental research methodology: Dental exam facility, Periotron 8000 DPC Immulite
ELISA plate reader and washer
Gas liquid chromatograph
High-pressure liquid chromatography
Nutrition research methodology: Nutrient analysis of various dietary intake records with appropriate nutrient databases; anthropometric evaluation with research quality tools; production of test formulas, constant nutrients, and weighed research meals
Perkin Elmer 1470 Wizard Gamma Counter
Perkin Elmer atomic absorption spectrophotometer (double beam)
Thin-layer chromatography capabilities

Major Areas of Investigation

Bone and Mineral Metabolism: Use of new therapies in treating elderly osteoporosis.

Cardiology: MRI as a diagnostic tool; angiogenesis treatments in ischemic myocardium; role of soy in coronary artery disease.

Endocrinology: Leptin physiology in obesity and neuroendocrine/leptin interactions; HIV lipodystrophy; role of omentectomy in treating obesity and resulting endocrine changes; relaxation response in acute stress.

Gastroenterology: Molecular etiology of and therapy for chronic pancreatitis; therapy for C. difficile colitis.

Gerontology: Mechanisms involved in syncope, falls, and cerebral vasoregulation.

Infectious Diseases: Treatment of AIDS, HIV infection; AIDS Clinical Trials Group; Phase I studies of AIDS-related Kaposi's sarcoma.

Nephrology: Islet cell transplantation in type 1 diabetes subjects.

Neurology: Neural plasticity in learning Braille; sleep deficit and immune function; mechanisms of orthostatic intolerance; genetics of epilepsy in epilepsy and cognitive disorders; cognitive and motor function in Parkinson's disease; prefrontal function in working memory; transcranial magnetic stimulation.

Oncology: Use of biologic agents in the treatment of advanced malignancy.

Psychiatry: Serotonin metabolism in eating disorders; psychobiology in eating disorders; cognitive function, mentation, and sleep.

Pulmonary Physiology: Pathophysiology and treatment of sleep apnea syndrome; sympathetic nervous system and sleep apnea; etiology of sarcoidosis.

Rheumatology: Immune modulation in therapy of rheumatoid arthritis; role of exercise in fibromyalgia; role of preoperative exercise in hip and knee arthroplasty.

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Beth Israel Deaconess Medical Center

General Clinical Research Center Satellite
The Forsyth Institute
140 The Fenway
Boston, MA 02115

Web site: http://www.forsyth.org

Major Areas of Investigation

The Forsyth Institute is the world's oldest and largest independent oral health research institution. Forsyth's clinical research program focuses on identifying the underlying causes of oral disease and better methods for effective treatment and prevention.

Microbial Genomics: Sequencing of periodontal pathogens.

Oral Microbiology: Biofilm development and ecology; species identification; checkerboard DNA-DNA hybridization; oral cancer.

Periodontal Disease Therapy: Local antimicrobial delivery; supra and subgingival plaque control; effects of combination therapies in smokers; refractory disease condition.

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Beth Israel Deaconess Medical Center

General Clinical Research Center Satellite
Joslin Diabetes Center
One Joslin Place
Boston, MA 02115

Web site: www.joslin.org

Major Areas of Investigation

Joslin Diabetes Center is one of the leading centers in diabetes education, treatment, and research. Clinical research done at the Joslin Diabetes Center focuses on diabetes mellitus and related metabolic disorders. The Joslin satellite also plays a significant role in training research fellows in endocrinology, diabetes, and metabolism.

Section on Behavioral and Mental Health: Studies associated with the epidemiology of diabetes and its complications, depression and brain structure in type 1 diabetes, and cognitive therapy in patients with type 1 and type 2 diabetes.

Section on Cellular and Molecular Physiology: Studies associated with the genetics of diabetes, insulin action in humans, the role of estrogen in vascular function in insulin-resistant women, the effects of salicylate on glucose metabolism in insulin-resistant states, and the role of insulin in the regulation of insulin secretion in B cells and studies of the physiologic and molecular determinants of diabetes.

Section on Clinical Research: The Diabetes Prevention Program Outcomes Study (DPPOS) continues to follow volunteers with impaired glucose tolerance, including those who have converted to type 2 diabetes, to determine the impact of intervention strategies on the development of cardiovascular disease and other long-term complications of diabetes. The Look AHEAD Trial is actively recruiting patients with established type 2 diabetes and randomizing them into an intensive lifestyle program focusing on weight reduction and increased physical activity or diabetes support and education group to determine the effects of lifestyle modification on cardiovascular event rates and other long-term complications of diabetes. In addition to these large NIH-funded multicenter trials, this section is also studying the effects of the angiotensin-converting enzyme inhibitor, quinipril, on vascular reactivity and endothelial function in patients with impaired glucose tolerance and type 2 diabetes with or without microalbuminuria. Also being conducted is a double-blind, randomized, placebo-controlled study of the effect of pioglitazone on vascular reactivity and endothelial function and on pancreatic beta cell function in patients with impaired glucose tolerance or established type 2 diabetes mellitus. Other studies are looking at the effects of weight loss on vascular reactivity, endothelial function and circulating markers of inflammation as well as visceral fat reduction by omentectomy as a potential treatment for obesity-related type 2 diabetes.

Section on Immunology and Immunogenetics: Studies associated with the Diabetes Prevention Trial for type 1 patients include studies of the genetic determinants of pathogenesis of autoimmune disease and studies of insulin receptor positive and autoantigen reactive T cells in human type 1 diabetes.

Section on Pediatrics: Studies associated with the metabolic and immunogenetic evaluation of relatives of patients with type 1 diabetes expressing "biochemical" anti-islet antibodies.

Section on Vascular Complications of Diabetes: Studies associated with the relationship between insulin resistance and vascular function in Chinese Americans.

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Boston University

General Clinical Research Center Admin. Office
Boston University School of Medicine
715 Albany Street, M-1016
Boston, MA 02118

Research Unit, Boston Medical Center
88 East Newton, Evans 8, Boston, MA 02118

Grant No. M01 RR00533

Special Assays, Services, or Tests

Special Resources, Instruments, or Services

Echocardiography
Hewlett Packard Series 60 real-time, phased-array imaging system and accessories for Doppler
Hologic bone densitometer
Indirect caloriometer
Marquette microprocessor-based exercise stress test EKG monitoring systems
Polysomography testing equipment
Videotaping laboratory

Major Areas of Investigation

Cardiovascular Diseases: Nitric oxide and the black vascular diathesis; cardiac amyloidosis; identification of subgroups with hypertension; oxidative stress and heart failure; glucose-insulin-potassium in coronary artery bypass graft; risk factors such as tobacco and buproprion; bypass angioplasty revascularization.

Child Development: Cocaine exposure in utero; secure environments; infant feeding behavior; neonatal hyper-algesia; autism.

Dentistry: Oral health in veterans; periodontitis; cigar smoking and periodontitis; cardiac events and periodontal prevention.

Endocrinology: Vitamin D₃ and its analogues in psoriasis and in cancer; osteoporosis and HIV; multinodular goiter, diabetes.

Geriatrics: Lecithin in Alzheimer's disease; outreach programs for the elderly; low muscle power and function in the elderly; pathways of stress on health decline in aged caregivers.

Infectious Diseases: Pharmacokinetic and new drug studies in adults with HIV; Lyme disease.

Men's Health: Violent injury in young black men; bone density in aging men of race and diversity.

Pediatrics: Pharmacokinetic studies in HIV-infected children; Williams syndrome; beta thalassemia.

Pulmonary Disease: Sleep apnea in children and people with congestive heart failure; snoring; IL-16 in asthma; exercise endurance in chronic obstructive pulmonary disease.

Rheumatology: Therapy for systemic lupus and scleroderma; amyloidosis; Wegener's granulomatosis; osteoarthritis; vasculitis.

Substance Abuse: Coordination of treatment and primary care; drug interactions in alcohol-dependent adults; treatment of cocaine dependence; evaluation of bipolar disease.

Women's Health: Breast cancer and exercise; assessment of estradiol-glucoside levels.

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Brigham and Women’s Hospital

General Clinical Research Center, Tower 9A
Brigham and Women’s Hospital
75 Francis Street
Boston, MA 02115

Grant No. M01 RR02635

Special Assays, Services, or Tests

Special Resources, Instruments, or Services

DNA processing
Group dining facilities for outpatients and controlled studies
Intensive physiological monitoring unit
Noninvasive cardiovascular ultrasound
Outpatient research kitchen

Major Areas of Investigation

Cardiovascular Diseases: Deep vein thrombosis; percutaneous transluminal coronary angioplasty and atherectomy; hypertension; endothelial function; congestive heart failure; coronary laser angioplasty; improving hormone profile during heart failure; noninvasive measures of vascular function.

Circadian Physiology and Sleep Disorders: Insomnia and disruptive sleep in the elderly; circadian rhythms in blind persons; circadian phase estimation after scheduled and unscheduled routine; circadian rhythms in shift rotation; homeostasis and circadian regulation of wakefulness during jet lag; melatonin as a hypnotic; effect of bright light in men versus women; effect of disruptive sleep on hormonal and renal responses to posture.

Endocrinology: Thyroid hormone secretion and metabolism; hormones in hypertension; angiotensin; parathyroid function; osteoporosis; racial differences in metabolism; bone metabolism.

Genetic Diseases: Genetics of hypertension; genetic epidemiology of early onset chronic obstructive pulmonary disease; glucocorticoid-suppressible hyperaldosteronism; risk intervention in sibling pairs; genetic predisposition in hypertension and diabetic nephropathy; oral glucose tolerance in aniridia; genetics of polycystic ovary syndrome (PCOS).

Geriatrics and Gerontology: Improving geriatric urge incontinence; cardiovascular and volume research in aging.

Hematology and Oncology: Bone marrow transplant; ovarian failure in breast cancer patients.

Infectious Diseases: AIDS; chronic fatigue syndrome; regulation of hormonal function in fibromyalgia; endotoxin, immunoneuroendocrine response to tetanus toxoid.

Metabolism: Diabetes mellitus; hyperinsulinemia and protein metabolism; hemodynamics and insulin-dependent diabetes mellitus; vascular function in diabetes; vanadate action in diabetes mellitus; lipoprotein and free fatty acid in insulin-dependent diabetes mellitus; insulin resistance; hypertension and diabetes.

Nephrology: Renal responses to angiotensin II; racial influences on the development of renal disease.

Neurology: Linomide in multiple sclerosis; MRI studies in multiple sclerosis; therapeutic treatment of multiple sclerosis; oral toleration to myelin antigen in multiple sclerosis; Parkinson's disease; Huntington's disease; epilepsy.

Nutrition: Glycemic index and weight loss, diabetes, and human physiology; effect of dietary patterns on blood pressure and lipids; circadian physiology; dietary treatment in Crohn's disease; endothelial function in renal disease; cocoa and polyphenols in renal function.

Obstetrics: Cellular immunity in recurrent miscarriage; insulin resistance and pregnancy-induced hypertension; sodium regulation and hypertensive complications of pregnancy; preeclampsia; HIV immunoglobulin for prevention of maternal-fetal HIV transmission in pregnant women.

Psychiatry: Seasonal affective light treatment; phototherapy.

Pulmonary Medicine: Aspirin-sensitive asthma; chronic obstructive pulmonary disease; respiratory control during extended wakefulness; glucocorticoid-induced osteopenia in pulmonary patients.

Space Medicine: Neurobehavioral hormonal and physiological adaptation to microgravity.

Women's Health: Preservation of gonadal function in bone marrow transplant; mechanisms by which estrogen and bone disorders affect bone mass; genetics of PCOS; premature ovarian failure in breast cancer patients; estrogen and vascular function in women; prevention of bone loss during early menopause; treatment of postmenopausal women.

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Children's Hospital

General Clinical Research Center
The Children's Hospital, 7 East
300 Longwood Avenue
Boston, MA 02115

Grant No. M01 RR02172

Special Assays, Services, or Tests

Analysis for genetic disorders: PCR and DNA sequence analysis

ELISAs: E-selectin, L-selectin, P-selectin, vascular cell adhesion molecule, intracellular adhesion molecule, IL-1ra, IL-1 beta, IL-2, IL-6, IL-12, fibroblast growth factor, vascular endothelial growth factor, tumor necrosis factor-alpha, tumor necrosis factor-alpha RI, interferon-gamma

Radioimmunoassays for metabolic disorders: corticotropin-releasing hormone, leptin

Special Resources, Instruments, or Services

DEXA, indirect calorimetry, bioelectric impedance analysis (BIA), anthropometry

Fully equipped sleep-study facility with lux spectrum lighting, adjacent observation rooms, and the ability to monitor patients in neighboring neonatal intensive care unit.

Major Areas of Investigation

AIDS: AIDS Clinical Trials Group studies; new treatment regimens for children with HIV infection.

Cardiology: Central nervous system sequelae of intraoperative perfusion techniques in infant cardiac surgery; evaluation of Fontan pathway hemodynamics; growth hormone for pediatric cardiac myopathy.

Endocrinology: Glycogen storage disease; obesity studies; DHEA for bone loss in cystic fibrosis and anorexia nervosa; dietary glycemic index and diabetes.

Gastroenterology: Nutritional failure in childhood HIV; treatment of steroid-refractory Crohn's disease; treatment of severe colitis; arginine metabolism in cystic fibrosis; treatment of pouchitis with clotrimazole; genetics of inflammatory bowel disease.

Genetic Diseases: Pregnancy outcomes of phenylketonuria (PKU) patients; Smith-Lemli-Opitz syndrome.

Hematology and Oncology: Clinical studies in bone marrow failure syndromes; clinical studies in thalassemia; studies of novel iron chelating agents in patients with transfusional iron overload; immunologic, genetic, and treatment studies in hemophilia; treatment of vascular malformations and defects in angiogenesis; sickle cell anemia.

Immunology and Rheumatology: Hereditary angioedema; studies on the cellular basis of immune defects in patients with antibody deficiency; primary immune deficiency studies.

Infectious Diseases: Women and infants HIV transmission study; HIV treatment studies.

Metabolism: Maternal phenylketonuria; dichloroacetate for mitochondrial disease; incidentally found hypoglycemia; amino acid requirements in critically ill patients; glutathione metabolism in children; growth hormone effect in children with short bowel syndrome.

Neonatology: Energy expenditure in premature neonates.

Nephrology: Induction therapy in renal transplantation; safety of oral Sirolimus in children undergoing hemodialysis.

Neurology: Developmental follow-up of premature infants.

Pulmonary Diseases: Gene therapy for cystic fibrosis; airway inflammation in cystic fibrosis.

Surgery: Marimastat for vascular anomalies; genetics of congenital diaphragmatic hernia.

Contact Information

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Massachusetts General Hospital

Mallinckrodt General Clinical Research Center
55 Fruit Street, White 13
Boston, MA 02114-2696

Web site: www.mgh.harvard.edu/GCRC

Grant No. M01 RR01066

Special Assays, Services, or Tests

Bone-specific alkaline phosphatase
Deoxypyridinoline
Frequent blood sampling for physiologic studies
Growth hormone
Insulin
N-telopeptide
Osteocalcin

Special Resources, Instruments, or Services

Controlled airflow isolation room for immunosuppressed and transplant patients

Graduate nursing student clinical research fellowship program

Nutrition services: Nutrient analysis of dietary intake; computerized diet planning for weighed diets; bioelectrical impedance analysis; anthropometry assessment; indirect calorimetry; behavior modification for nutrition intervention; DEXA for measurement of bone density and body composition

Premedical and medical student fellowship program

Major Areas of Investigation

Aging: Evaluation of physiology of aging, including cardiovascular and metabolic changes in the very elderly.

Anesthesiology: Innovative therapy of pain syndromes.

Diabetes: Innovative treatments with external and implantable programmable insulin-infusion pumps and islet transplantation, role of glycemic control in pathogenesis of long-term complications; role of endogenous insulinotropic hormones in pathogenesis and treatment of type 2 diabetes mellitus; prevention of diabetes; amelioration of cardiovascular risk factors in diabetes.

Endocrinology: Parathyroid hormone physiological effects; hyperparathyroidism; thyroid-stimulating hormone secretion and metabolism; vitamin D metabolism; hypothalamic-pituitary axis in children; physiological effects of hyperthyroidism and hypothyroidism; diagnostic use of serum prolactin and somatomedin assays; pathophysiology and treatment of osteoporosis and other metabolic bone diseases.

Gastroenterology: Development and implementation of treatments of hepatitis B and C; novel treatments of inflammatory bowel disease.

Genetic Diseases: Treatment of Gaucher's disease with enzyme replacement; gene therapy of cystic fibrosis.

Infectious Diseases: AIDS Clinical Trials Group protocols; vaccine studies for typhoid, Listeria.

Neuroendocrinology: Hypogonadism and osteoporosis; pathogenesis and regulation of ACTH-producing pituitary adenomas; octreotide therapy of clinically nonfunctioning pituitary adenomas; long-term effects of growth hormone in adults with GH deficiency; AIDS wasting syndrome.

Neurology: Investigation of new drugs for Parkinson's disease, Alzheimer's disease, amyotrophic lateral sclerosis, and progressive supranuclear palsy.

Neuropsychiatry: Neuroendocrine effects of antipsychotic drugs; depression and Cushing's disease; neuroendocrine mechanisms in anxiety; mechanisms of and treatments for addictive disorders; functional NMR studies of addiction.

Oncology: Treatment of metastatic adenocarcinoma with chimeric antibody and ovarian cancer with mullerian inhibitory factor.

Pediatrics: Treatment of precocious puberty with gonadotropin-releasing hormone analog; pubertal changes in bone mass, and treatment of diabetes in children.

Psychiatry: Pharmacologic treatment of obsessive-compulsive disorder; biochemical changes in cerebrospinal fluid in tardive dyskinesia and in addictive states; pharmacokinetics of psychotropic drugs.

Reproductive Endocrinology and Gynecology: Exercise-induced reproductive disturbances; physiology of gonadotropin release in normal women and patients with reproductive disorders; treatment of idiopathic hypogonadotropic hypogonadism; interaction of androgen, estrogen, and insulin in women with polycystic ovary syndrome and in women with insulin resistance.

Rheumatology: Novel therapies for rheumatoid arthritis and other inflammatory joint diseases.

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Massachusetts Institute of Technology Satellite

General Clinical Research Center Satellite
Massachusetts Institute of Technology
77 Massachusetts Avenue
Cambridge, MA 02139-4307

Grant No. M01 RR01066

Special Assays, Services, or Tests

Assays for melatonin; amino acids (including tryptophan)

Dual-energy X-ray absorptiometry (DEXA) for bone density and body composition measurements

Facilities for quantifying intake of calories, proteins, carbohydrates, and fats from meals and snacks by inpatients and outpatients

Indirect calorimetry

Isotope ratio and GC/MS

Metabolic studies with stable isotopes, using mass spectroscopy and neutron activation
Psychiatric and behavioral testing

Major Areas of Investigation

Clinical Neuropharmacology: Behavioral effects of neurotransmitter precursors (tryptophan, tyrosine, lecithin), foods (carbohydrates, proteins); effects of experimental drugs in memory disorders; clinical pharmacology of seasonal depression and of premenstrual syndrome; effects of drugs (e.g., citicoline, uridine) on memory in aged and memory-impaired individuals; effects of serotoninergic drugs in depression and weight gain.

Endocrinology: Metabolic alterations in women with prior complications of pregnancy.

Geriatrics and Gerontology: Nutrient preferences of the elderly; behavioral effects of nutrients in the elderly; protein and energy metabolism.

Investigator-Initiated Programs: The program in nutrition and metabolism investigates relationships among nutrition, body composition, and hormonal function; the program in women's health studies psychological aspects of premenstrual syndrome (PMS) and menopause; the program in applied technology and communications in health care seeks to develop new avenues for health care delivery through strategic applications of novel technologies such as telerehabilitation in stroke patients.

Neuroendocrinology: Lipodystrophy syndrome in HIV-infected individuals; effects of anorexia nervosa on development of peak bone mass during pubertal development, effects on the growth hormone and reproductive endocrine axes.

Neurology: Functional neuroimaging and biochemical markers of acute stroke; cognitive impairment of acute stroke.

Neuropsychology: Effects of brain injury; effect of dietary precursors of neurotransmitters on memory loss in Alzheimer's disease; application of information technology in health care.

Nutrition: Protein and amino acid requirements of humans; starvation and refeeding; protein-wasting states; effects of infection on protein metabolism; treatment of obesity; nutritional requirements in the elderly; protein tolerance; protein-sparing diets; effects of exercise; protein and glucose turnover in various nutritional states and at various ages; new protein sources; energy metabolism; factors influencing plasma branched-chain amino acid levels in obesity; phenylalanine metabolism in subjects on phenylalanine-rich diets; relationship among nutrition, body composition, and hormonal function.

Obesity: Characterization of abnormal patterns of nutrient intake (e.g., carbohydrate snacking) and of responses to drugs; characterization of O₂ consumption and CO₂ production by ambulatory subjects after particular foods or drugs; obesity in adolescents.

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