Overview

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 influence on the science of research through extensive publications and presentations of data at international conferences and symposia.

Research Experience

For well over a decade, L-MARC has been involved in metabolic clinical research and has conducted more than 500 phase 1 to 4 clinical trials in therapeutic areas including:

• Obesity – with and without DXA;
• Diabetes mellitus;
• Dyslipidemia – hypercholesterolemia and hypertriglyceridemia;
• Hypertension;
• Endocrine/metabolic – osteoporosis, hormone replacement therapy for menopause;
• Cardiovascular – cardiovascular outcomes trials;
• Fatty liver/NAFLD ;
• Musculoskeletal – gout, osteoarthritis, rheumatoid arthritis;
• Pain;
• Migraine headaches; and
• Device studies for metabolic disease monitoring – glucose, lipids, vitamin levels.

Facility Description

L-MARC, an independent research center, is centrally located in the Louisville, Ky., metropolitan area only 10 minutes from Louisville International Airport and less than one mile from Norton Audubon Hospital. The research center is fully equipped and is able to conduct various research procedures, such as:

• Radiology;
• Mammograms;
• DEXA scanning;
• MRI/CT scans;
• Echocardiograms; and
• EKG.

The center also features:

• Laboratory freezer (-20°, -40° and -70°);
• 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; and
• A designated and spacious "Research Atrium" for study monitors, with individual desks, phones, rapid-access modem access and wireless access, close to fax and copy equipment.

Investigator

Harold Bays MD, FOMA, FTOS, FACC, FACE, FNLA

Dr. Harold Bays has served as an investigator for more than 500 phase 1 to 4 clinical trials for treatments for high cholesterol and other dyslipidemias, obesity, diabetes mellitus, hypertension, osteoporosis and other metabolic and hormonal disorders. Dr. Bays has served as medical director of L-MARC Research Center since 1989 and has served as president of L-MARC Research Center since its independent incorporation in 1998.  He has written or served as a contributing author to well over 200 PubMed-searchable, peer-reviewed scientific manuscripts and book chapters and has authored/presented more than 100 scientific abstracts. 

Professional Memberships

• Fellow of the Obesity Medicine Association (FOMA)
• Fellow of the Obesity Society (FTOS);
• Fellow of the American College of Cardiology (FACC)
• Fellow of the American Association of Clinical Endocrinologists (FACE)
• Fellow of the National Lipid Association (FNLA)

Scientific Memberships

• Obesity Medicine Association
• The Obesity Society
• National Lipid Association
• American Society of Preventive Cardiology
• The Endocrine Society
• American Association of Clinical Endocrinologists
• American College of Cardiology
• American Diabetes Association (ADA) – recognized provider in the ADAs National   Committee for Quality Assurance from 1998 to 2010
• Kentucky Medical Association
• Greater Louisville Medical Society

Chairmanships

• Obesity Medicine Association Obesity Algorithm (2016-present)
• The Obesity Society Membership Committee (2012-2014)
• National Lipid Association Adiposity and Dyslipidemia Consensus Conference (2012)
• American Association of Clinical Endocrinologist Adipose Tissue Pathophysiology State of the Science Conference (2010)
• American Association of Clinical Endocrinologist Pathogenic Adipose Tissue Task Force (2006-2010)
• "Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes" (SHIELD) (2003-2011)
• Endocrine Subcommittee for Alternative Health Delivery Systems (1996-7)

Scientific Boards

• Obesity Medicine Association
• American Board of Clinical Lipidology (2017-present)
• National Lipid Association (2013-2017)
• Southeast Lipid Association (2009-2017)
• American Association of Clinical Endocrinologists (2010)

Scientific Committee, Officer and Task Force Positions

• Executive Officer: National Lipid Association Secretary/Treasurer (2015-2017)
• President:  Southeast Lipid Association (2015-2016)
• Committee Member:  The Obesity Society Education Committee (2013-2015)
• The Obesity Society, Presenter for the American Board of Obesity Medicine Review Course (2013-present)
• Contributing author of the National Lipid Association Annual Summary of Clinical Lipidology (2015-2016)
• Contributing author of the National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia, Part 1 (2014)
• Contributor to the National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia, Part 2 (2015)
• Contributing author to the Obesity Medicine Association Obesity Algorithm (2013-present)

Scientific Editorships

• Guest editor and lead author of the National Lipid Association Annual Summary of Clinical Lipidology (2016)
• Guest editor and lead author of the National Lipid Association Annual Summary of Clinical Lipidology (2015)
• Associate editor of the Journal of Clinical Lipidology (2013-2017)
• Scientific writer,  Obesity Medicine Association Obesity Algorithm (2013-present)

Awards

• 2016 Obesity Medicine Association Obesity Medicine Clinician of the Year
• 2015 National Lipid Association President’s Service Award
• 2014 Obesity Medicine Association Committee Leadership Award

Staff Expertise

Sarah Keiran RN, BSN, CCRC
Senior Clinical Research Coordinator
19 years of experience in clinical research

Nikki Nockerts, RN, BSN, CCRC
Certified Clinical Research Coordinator
13 years of experience in clinical research

Melanie Moore, APRN, CCRC
Sub-investigator/Certified Clinical Research Coordinator
Six years of experience in clinical research

Barbara Michelle Ritchey, ARNP, CCRC
Sub-investigator/Clinical Research Coordinator
10 years of experience in clinical research

Taylor Codey, APRN
Sub-investigator/Clinical Research Coordinator
One year of experience in clinical research

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

Tammy Jackson, MA
Clinical Research Laboratory
14 years of experience in clinical research

Susie Lucas, MA
EDC Specialist/Clinical Research Laboratory
2 years of experience in clinical research

Samantha Thomas, BS
Recruitment Specialist
2 years of experience in clinical research

Debbie Conliffe, BS
Research Assistant
14 years of experience in clinical research

Noreen Behl
Research Assistant
10 years of experience in clinical research

Jerry Seadler
Environmental Services

Olivia Kelly, RD, LD, CD
Site Manager
3 years of experience in clinical research

Coury Hobbs, RN, BSN
Business Manager
11 years of experience in clinical research

Patient Demographics

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 a diverse population of subjects of various racial and ethnic backgrounds, socioeconomic classes, and gender. L-MARC has a database of research volunteers that can be accessed for patient recruitment.

Other Information

As an independent research site, L-MARC utilizes central IRBs.

L-MARC has been the top randomizing site in multiple clinical trials and has extensive experience in remote data entry and internet data entry in multiple clinical trials with multiple different study sponsors. Most of all, L-MARC Research Center is committed to the highest of quality research with established standard operating procedures and routine monthly quality assurance audits.