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
• EKG

The center also features:

• Laboratory freezer (-20°, -40° and -80°);
• Free parking and access to public transportation;
• Study participant database
• Wired and wireless Internet
• "Research Atrium" exclusively for study monitors, which is a spacious dedicated research work area with study monitor desks, phones, and access to fax and copy equipment.

Investigator

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

Dr. Harold Bays is Medical Director and President of the Louisville Metabolic and Atherosclerosis Research Center, Inc. (L-MARC), as well as Your Body Goal.  He has served as a Principal Investigator for over 500 clinical trials of metabolic therapeutic interventions.  Dr. Bays is Board Certified in Internal Medicine and Endocrinology and Metabolism, Diplomate of the American Board of Obesity Medicine, and a Diplomate of the American Board of Clinical Lipidology.  He is a Fellow of the Obesity Medicine Association, The Obesity Society, the American College of Cardiology, the American Association of Clinical Endocrinologists, the National Lipid Association, and the American Society of Preventive Cardiology.  Dr. Bays has written or served as a contributing author to over 300 scientific manuscripts and book chapters and authored/presented 100’s of scientific abstracts.  He has served as a Board of Director and Executive Officer of Scientific Organizations, served as the Chairman for many scientific projects, and authored a number of Scientific Consensus and Clinical Practice Statements and National Recommendations.  Dr. Bays is the Chief Science Officer for the Obesity Medicine Association, member of the Board of Trustees of the Obesity Medicine Association, and is Editor-in-Chief of Obesity Pillars (official journal of the Obesity Medicine Association). Among his awards include the 2015 National Lipid Association “President’s Service Award” and the 2016 Obesity Medicine Association “Obesity Medicine Clinician of the Year.”

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 National Lipid Association (FNLA)
• Fellow of the American Society of Preventive Cardiology

Scientific Memberships

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

Chairmanships

• Obesity Medicine Association Obesity Algorithm (2016-2021)
• 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

• Board of Trustees:  Obesity Medicine Association (2018 - Present)
• Board of Directors:  American Society of Preventive Cardiology (2019 – 2022)
• Board of Directors:  National Lipid Association (2013 – 2019)
• Board of Directors:  American Board of Clinical Lipidology (2017 - 2019)
• Board of Directors:  South East Lipid Association (2009 – 2017)
• Board of Directors:  American Association of Clinical Endocrinologists (2010)

Scientific Committee, Officer and Task Force Positions

• Vice President Obesity Medicine Association (2022 – present)
• Treasurer/Secretary Obesity Medicine Association (2021 – 2022)
• 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

• Editor in Chief:  Obesity Pillars – Journal of the Obesity Medicine Association (2021 – present)
• Editor:  Obesity Medicine Association (OMA) Self-Assessment Program (SAP) 2020
• Associate Editor:  Journal of Preventive Cardiology (2019 – 2021)
• 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 (2013-2021)

Awards

• 2019:  Obesity Medicine Association “Dr. Peter G. Linder Award”
• 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
24 years of experience in clinical research

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

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

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

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

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

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

Lisa Wise, CMA
EDC Specialist/Clinical Research Laboratory
1 year of experience in clinical research

Ashley Sadler, CPhT
Recruitment Specialist
1 year of experience in clinical research

Jerry Seadler
Environmental Services

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

Coury Hobbs, RN, BSN
Business Manager
15 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.