Since 1986, Louisville Metabolic and Atherosclerosis Research Center (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
• Ehocardiograms
• 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 300 clinical 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 100 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 Research Coordinator
8 years experience in clinical research

Becky Whitehead RN, BSN, CCRC - Senior Research Coordinator
6 years experience in clinical research

Michelle Mike, RN, BSN, ANP - Clinical Research Coordinator
5 years experience in clinical research

Nikki Nockerts, RN, BSN, CCRC - Senior Clinical Research Coordinator
5 years experience in clinical research

Lisa McLaughlin, RN, BSN - Clinical Research Coordinator
3 years experience in clinical research as of 1/2004

Maureen McAllister, ARNP - Sub Investigator/Clinical Research Coordinator
13 years experience as a Nurse Practitioner

Erin Brady RN, BSN - Clinical Research Coordinator
3 years nursing experience

Amy Graf RD, LD - Research Dietitian/Clinical Research Coordinator
2 years experience in dietetics

Heather Montgomery RDE - Research Dietitian/Recruitment Specialist
3 years experience in clinical research

Jean Micklewright RD, LD- Director of Dietary Programs / Research Dietitian
5 years experience in clinical research

Tammy Jackson - Clinical Research Laboratory
3 years experience in clinical research

Christina Shelton - Clinical Research Laboratory
2 years experience in clinical research

Debbie Meredith BS - Research Assistant
8 years experience in clinical research

Debbie Conliffe BS - Research Assistant
7 years experience in clinical research

Kathy Roberts - Electronic Data Capture / Research Administrative Assistant
2 years experience in clinical research

Jerry Seadler - Environmental Services

Christian Ralston RN, BSN - Clinical Research Coordinator
5 years nursing experience

Brian Dawson RN, BSN - Site Manager
3 years experience in clinical research

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.

To view a list of our currently enrolling studies, please click here.

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

CenterWatch is listing the following trials that are actively recruiting patients at this center.

• A Randomized-Withdrawal Phase III Study Evaluating the Safety and Efficacy of CG5503 Extended-Release (ER) in Subjects with Painful Diabetic Peripheral Neuropathy (DPN)

For more information, please contact:

Brian Dawson, RN, BSN
Site Administrator
L-MARC Research Center
3288 Illinois Avenue
Louisville, KY 40213 USA
Phone: 502-214-3990
Fax: 502-214-3999
E-mail:

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the E-mail form below. A representative from the research center will then follow up with you.

Name:
Address:
City:
State:
Zip:
Phone:
Email address:
Message:

Please note: A number of commercial online services display an error message after you click on Send. Please be assured that your message has been received.

Last updated on October 8, 2008