Research Center Profile:
Cardiology/Vascular Diseases
Since 1986, L ouisville
M etabolic and A therosclerosis
R esearch C enter (L-MARC Research
Center) has been one of the most active metabolic research centers
in the world. One of the unique aspects of L-MARC Research Center,
in addition to a commitment to research quality, has been a strong
emphasis on the science of research through extensive publications
and presentations of data at international conferences and
symposia. For a more complete description of L-MARC Research
Center, past clinical trials, a listing of publications, please see
the extensive website at www.lmarc.com .
For well over a decade, L-MARC Research Center has been involved
in metabolic clinical research and has conducted over 300 Phase I
through IV clinical trials including:
Cardiovascular - Hyperlipidemia, hypertension,
atherosclerosis
Endocrine/Metabolic - Obesity, type 2 diabetes mellitus, lipid
disorders, osteoporosis, hormone replacement therapy for menopause,
thyroid disorders, hypertension
Musculoskeletal - Osteoarthritis, osteoporosis, rheumatoid
arthritis
For a listing of past and current clinical trials, please visit
L-MARC Research Center’s website at www.lmarc.com .
L-MARC is an independent research center located in Louisville,
Kentucky, centrally located in the Louisville metropolitan area
only ten minutes from Louisville International Airport. The
research center is fully equipped and located less than one mile
from Norton Audubon Hospital and is able to conduct various
research procedures such as:
Radiology
Mammograms
DEXA Scanning
MRI/CT Scans
Echocardiograms
Laboratory freezer (-20° and -70° degrees)
EKG
Free Parking and access to public transportation
Study Manager Database (clinical trials management software
system) with study subject database
State-of-the art computer capabilities with wireless rapid
Internet access
Designated study monitor areas with amenities
For a more complete listing of facility matters of interest to
Study Sponsor and Study Monitor, please visit the website at
www.lmarc.com
Harold E. Bays MD, FACP
Harold Bays, MD, FACP is Medical Director and President of
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
and continues to see oversee patient care for Louisville
Endocrinology P.S.C., - a private medical practice in Louisville,
Kentucky. Dr. Bays received his medical degree, completed his
Internship and Residency in Internal Medicine, and received his
Fellowship in Endocrinology and Metabolism all at the University of
Louisville School of Medicine. He is board certified in both
Internal Medicine and Endocrinology and Metabolism.
Dr. Bays has served as a Principal Investigator for over 400clinical trials, including studies of all currently marketed lipid-altering drug treatments, as well as studies of investigational drugs for obesity, diabetes mellitus, hypertension, osteoporosis, osteoarthritis, and other metabolic disorders. He has written, or has been a contributing author to over 250 published peer-reviewed scientific manuscripts, abstracts, and medical/scientific book chapters. Specifically, he has been a published author in journals such as: Obesity Research, Journal
of Clinical Endocrinology and Metabolism, Medical Clinics of North
America, Metabolism, Drug Development & Research, Circulation,
Atherosclerosis, Expert Opinion on Investigational Drugs, Journal
of Cardiovascular Therapy, Expert Opinion on Pharmacotherapy,
Progress in Drug Research, Journal of Clinical Pharmacology,
American Journal of Cardiology, Drug Safety, Clinical Therapeutics,
Journal of Clinical Investigations in Arteriosclerosis, American
Journal of Kidney Disease, American Journal of Cardiovascular
Drugs, Preventive Cardiology, Expert Review of Cardiovascular
Therapy, Evidence-based Cardiovascular Medicine, European Heart
Journal, Clinical Cardiology, Future Cardiology, International
Journal of Clinical Practice, Coronary Artery Disease, Hospital
Pharmacy Europe, Nature Clinical Practice Cardiovascular Medicine,
Nutrition Metabolism & Cardiovascular Disease, Journal of
Women’s Health, and is a scientific contributor to
www.lipidsonline.org .
Dr. Bays originated the term "adiposopathy", which is
defined as pathogenic adipose tissue which is promoted by positive
caloric balance and sedentary lifestyle in genetically and
environmentally susceptible patients, which may be anatomically
manifested by adipocyte hypertrophy, visceral adipose tissue
accumulation, and ectopic fat deposition, and physiologically
results in adverse metabolic and immune consequences resulting in
clinical metabolic disease. He has published several manuscripts on
the adipocentric paradigm wherein pathogenic adipose tissue
represents a rational, unifying cause of excessive fat-related
metabolic diseases. Dr. Bays is Chairman of the American
Association of Clinical Endocrinologists (AACE) Task Force on
Pathogenic Adipose Tissue and Metabolic Disease. Dr. Bays is also
Chairman of the study group overseeing the "Study to Help
Improve Early evaluation and management of risk factors Leading to
Diabetes" (SHIELD), which is the largest survey of its kind,
designed as a cross-sectional and subsequent longitudinal study of
various parameters relevant to metabolic diseases, including
diabetes mellitus.
He has served as an expert manuscript reviewer for scientific
medical journals including: Journal of the American Medical
Association (JAMA), The Lancet, Archives of Internal Medicine,
Obesity Research/Obesity, Journal of the American College of
Cardiology (JACC), Methods and Findings in Experimental and
Clinical Pharmacology, Opinion in Molecular Therapeutics, Annuals
of Nutrition and Metabolism, Biochemical Pharmacology, Vascular
Health and Risk Management, Drug Discovery Today, Investigational
Drug Database, Trends in Pharmacological Sciences, Expert Opinion
on Biologic Therapy, Drugs, Journal of the American College of
Nutrition, American Journal of Cardiovascular Drugs, Expert Opinion
on Pharmacotherapy, Expert Opinion on Investigational Drugs,
International Journal of Clinical Practice, Pharmacological
Research, Expert Opinion on Drug Safety, Consultant, Future
Lipidology, Nature Clinical Practice Cardiovascular Medicine,
Expert Opinion on Therapeutic Targets, Treatments in Endocrinology,
Journal of Clinical Outcomes Management, Vascular Health and Risk
Management, and Journal of Cardiovascular Drugs. . Dr. Bays has
presented poster abstracts and/or given oral presentations of
abstracts regarding cardiovascular disease, obesity, and diabetes
mellitus at various scientific meetings, international symposia,
and university conferences.
Finally, Dr. Bays serves as a national and international advisor
and consultant for pharmaceutical companies in protocol and drug
project development, and has given hundreds of invited educational
presentations, including Continuing Educational Education (CME)
programs.
Dr. Bays is a Fellow of the North American Association for the
Study of Obesity (NAASO) and a Fellow of the American College of
Physicians (FACP). He is a member of the American Diabetes
Association (ADA) - and has been a “Recognized” provider in the
ADA’s NCQA Diabetes Physician Recognition Program since 1998. Dr.
Bays is also a member of the American Association of Clinical
Endocrinologists (AACE), the American Society of Bariatric
Physicians (ASBP), the American Medical Association (AMA), the
Kentucky Medical Association (KMA) and has been honored with
academic awards, as well as for his longstanding physician
volunteer work for the homeless.
Sarah Keiran RN, BSN, CCRC Senior Clinical Research Coordinator
Becky Whitehead RN, BSN, CCRC Senior Clinical Research Coordinator
Melanie Moore, APRN, CRC Sub Investigator/Certified Clinical Research Coordinator
Carolyn Williams RD, LD, CCRC Senior Clinical Research Coordinator
Kathy Schmitz RD, LD CRC Clinical Research Coordinator
Maureen McAllister, ARNP, CCRC Sub Investigator/Certified Clinical Research Coordinator
Barbara Michelle Ritchey, ARNP, CRC Sub Investigator/Clinical Research Coordinator
Frank A. Walker, MD Sub Investigator
Jean Micklewright RD, LD Director of Dietary Programs / Research Dietitian
Tammy Jackson Clinical Research Laboratory
Christina Shelton Clinical Research Laboratory
Debbie Conliffe BS Research Assistant
Kathy Roberts Electronic Data Capture / Research Administrative Assistant
Denise Bushong, APRN, CRC Sub Investigator/Clinical Research Coordinator
Jerry Seadler Environmental Services
Kathy Schmitz, RD, LD, CCRC Site Manager
L-MARC is located in Louisville which is the largest city in the
Commonwealth of Kentucky. Louisville is located across the Ohio
River from Indiana, therefore allowing for large populations of
study volunteers from several counties in southern Indiana as well
as surrounding counties in Kentucky. The Louisville metropolitan
area is comprised of seven counties (three in Kentucky and four in
Indiana) with a population of 1.2 million. A good number of study
volunteers are willing to travel to Louisville from rural parts of
the state to participate in clinical trials. With its central
location, L-MARC attracts subjects of various socioeconomic class,
ethnic background, race and gender. L-MARC has a data base of
research volunteers in the Study Manager program that can be
accessed for patient recruitment.
As an independent research site, L-MARC utilizes central
IRB's. L-MARC has been the top randomizing site in multiple
clinical trials, and has extensive experienced in Remote Data Entry
and Internet Data Entry in multiple clinical trials with multiple
different study sponsors. L-MARC facilities include designated
workspaces for study monitors with phone and analogue and
rapid-access modem access. The areas are located close to fax and
copy equipment. But most of all, L-MARC Research Center is
committed to the highest of quality research with established
Quality Assurance plan and Standard Operating Procedures in
place.
For a more complete general description of L-MARC Research
Center, and quality assurance measures in place, please visit the
L-MARC Research Center website at www.lmarc.com .
L-MARC Research Center is currently
enrolling for the following:
Trials Involving Weight Loss
Trials Involving Hypertension
Trials Involving Cholesterol
Trials Involving Triglycerides
Trials Involving Diabetes and Related
Disorders
Trials Involving Osteoarthritis
Trials Involving Rheumatoid Arthritis
Trials Involving Pain Control
If you are interested in contacting this center to discuss placing a clinical
trial there, please complete and send the email form below. A representative from
the research center will then follow up with you.
