Overview

Since 1986, LouisvilleMetabolic and AtherosclerosisResearch Center (L-MARC ResearchCenter) has been one of the most active metabolic research centersin the world. One of the unique aspects of L-MARC Research Center,in addition to a commitment to research quality, has been a strongemphasis on the science of research through extensive publicationsand presentations of data at international conferences andsymposia. For a more complete description of L-MARC ResearchCenter, past clinical trials, a listing of publications, please seethe extensive website at www.lmarc.com.

Experience

For well over a decade, L-MARC Research Center has been involvedin metabolic clinical research and has conducted over 500 Phase 1 through IV clinical trials 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 (non-alcoholic fatty liver disease)
• Musculoskeletal – Gout, osteoarthritis, rheumatoid arthritis
• Pain
• Migraine headaches
• Device studies for metabolic disease monitoring (glucose, lipids, vitamin levels
• For a listing of past and current clinical trials, please visit L--MARC Research Center’s website at www.lmarc.com.

Facility

L-MARC is an independent research center located in Louisville,Kentucky, centrally located in the Louisville metropolitan areaonly ten minutes from Louisville International Airport. Theresearch center is fully equipped and located less than one milefrom Norton Audubon Hospital and is able to conduct variousresearch procedures such as:

• Radiology
• Mammograms
• DXA Scanning
• MRI/CT Scans
• Echocardiograms
• Laboratory freezer (-20°, -40° 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 atwww.lmarc.com

Investigator

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

Dr. Harold Bays has served as an Investigator for over 500 Phase I - IV 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 Pub-Med searchable, peer review scientific manuscripts and book chapters, and authored/presented over 100 scientific abstracts. 

Professional Membership Fellow

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

Member:  Obesity Medicine Association

Member:  The Obesity Society (TOS)

Member:  National Lipid Association (NLA)

Member:  American Society of Preventive Cardiology (ASPC)

Member:  The Endocrine Society

Member:  American Association of Clinical Endocrinologists (AACE)

Member:  American College of Cardiology (ACC)

Member: American Diabetes Association (ADA) – Recognized Provider in the ADA's National Committee for Quality Assurance (NCQA) from 1998 - 2010

Member:  Kentucky Medical Association (KMA)

Member:  Greater Louisville Medical Society (GLMS)

Chairmanships

Chairman:  The Obesity Medicine Association Obesity Algorithm (2016 – Present)

Chairman:  The Obesity Society Membership Committee (2012-2014)

Chairman:  National Lipid Association Adiposity and Dyslipidemia Consensus Conference 2012

Chairman: American Association of Clinical Endocrinologist Adipose Tissue Pathophysiology State of the Science Conference - 2010

Chairman:  American Association of Clinical Endocrinologist Pathogenic Adipose Tissue Task Force (2006-2010)

Chairman:  "Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes" (SHIELD) (2003 – 2011)

Chairman: Endocrine Subcommittee for Alternative Health Delivery Systems - (1996-7)

Scientific Board of Directors

Board of Directors:  Obesity Medicine Association

Board of Directors:  National Lipid Association

Board of Directors:  American Board of Clinical Lipidology (2017 - )

Board of Directors:  National Lipid Association (2013 – 2017)

Board of Directors:  South East Lipid Association (2009 – 2017)

Board of Directors:  American Association of Clinical Endocrinologists (2010)

Scientific Committees, Officer, and Task Force

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 (ABOM) 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 Editor

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:  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

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

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

Melanie Moore, APRN, CCRC
Sub Investigator/Certified Clinical Research Coordinator
6 years experience in clinical research

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

Taylor Codey, APRN
Sub Investigator/Clinical Research Coordinator
1 year experience in clinical research

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

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

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

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

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

Noreen Behl
Research Assistant
10 years experience in clinical research

Jerry Seadler
Environmental Services

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

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

Patients

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 background, socioeconomic class, and gender. L-MARC has a data base of research volunteers that can be accessed for patient recruitment.

Other

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 a designated and spacious "Research Atrium" for study monitors with individual desks, phones, rapid-access modem access, and wireless access. The areas are located close to fax and copy equipment. Most of all, L-MARC Research Center is committed to the highest of quality research with established Standard Operating Procedures routine monthly quality assurance audits.

For a more complete general description of L-MARC ResearchCenter, and quality assurance measures in place, please visit theL-MARC Research Center website at www.lmarc.com.

L-MARC Research Center is currentlyenrolling for the following:

Trials Involving Weight Loss

Trials Involving Hypertension

Trials Involving Cholesterol

Trials Involving Triglycerides

Trials Involving Diabetes and RelatedDisorders

Trials Involving Osteoarthritis

Trials Involving Rheumatoid Arthritis

Trials Involving Pain Control

Trials involving Migraines

Trials involving Gout