Facilities & Services

Onsite Services

Biostatistics

The Biostatistics group at Pennington Biomedical Research Center is comprised of biostatisticians and data management teams. Through collaboration with fellow scientists, our biostatisticians provide statistical support for clinical and non-clinical studies conducted at Pennington. The data management team consists of systems analysts and applications programmers who create and maintain the central clinical database.

Biostatistical functions include general statistical consultation, experimental design consultation, sample size determination and power analyses, data analysis and interpretation, and reporting of results of clinical studies. In addition, our biostatisticians pursue independent research in statistical theory and methods related to the planning and conduct of clinical trials.

The database management team’s primary responsibility is the implementation and maintenance of the Central Clinical Database, the institution's primary archive of clinical research data. In addition, our programmers are charged with development of the specialized applications that are used to collect clinical data from diverse sources throughout the institution. This group is also responsible for the continuing development of Clinical Data Access (CDA), an internal application that provides authorized users a secure web-based portal to the clinical database.

Clinical Research Laboratory

The Clinical Research Laboratory is directed by Jennifer Rood, Ph.D., DABCC, FACB.  Dr. Rood has initiated rigid quality control systems in the laboratory and it is accredited by the Health Care Financing Administration (HCFA) and the College of American Pathologists (CAP).  The laboratory also participates in the lipid standardization program of the Centers for Disease Control.  The Good Clinical Practice guidelines are followed in the laboratory.  The Clinical Research Laboratory at Pennington Biomedical Research Center performs analyses for our clinical trials, basic researchers, the US Army Institute of Environmental Medicine (USARIEM), and for contracting clients.  The Clinical Research Laboratory is staffed by licensed medical technologists, phlebotomists, and accessioners.  It is subdivided into the following departments:  phlebotomy, accessioning, chemistry, hematology, urinalysis, special chemistry and point-of-care testing.

The laboratory is well-equipped for performing routine and specialized tests on clinical subjects. 

Instrumentation and assays available include, but not limited to the following:

  • Agilent Technologies HPLC :  3 methyl histidine, alanine, alpha carotene, alpha tocopherol, asymmetric dimethyl arginine, arginine, asparagine, beta carotene, bromide, cryptoxanthin, glutamic acid, glutamine, glutathione, glycine, histidine, isoleucine, leucine,  lutein, lycopene, lysine, methionine, phenylalanine, retinol, serine, threonine, tryptophan, tyrosine, valine, zeaxanthin.
  • Alcohawk Precision :   breath alcohol
  • Alco Scan :   breath alcohol
  • Antek 9000:  nitrogen (urine, fecal, sweat, and saliva)
  • Bayer Clinitek 50:  urine microalbumin
  • Bayer Clinitek 200:  urine blood, pH, glucose, ketones, leukocyte esterase, nitrite, protein, specific gravity, urobilinogen
  • Beckman Coulter Array:  apolipoprotein A1, apolipoprotein B100, ceruloplasmin, haptoglobin, retinol binding protein, transferring, Lp(a), Ig A, Ig G, and Ig M          
  • Beckman Coulter Hmx:  red blood cell count, hemoglobin, hematocrit, MCV, MCH, MCHC, RDW, platelet count, mean platelet volume, white blood cell count, basophils, eosinophils, lymphocytes, monocytes, neutrophils, reticulocytes, absolute granulocytes
  • Beckman Coulter DXC600:  acetaminophen, albumin, alkaline phosphatase, ALT, amylase, AST, blood urea nitrogen, calcium, carbon dioxide, chloride, cholesterol, creatine kinase, creatinine, direct bilirubin, glucose, GGT, HDL cholesterol, hemoglobin A1C, iron, lactate dehydrogenase, LDL cholesterol, magnesium, osmolality, phosphorus, potassium, sodium, total bilirubin, total iron binding capacity, % iron saturation, total protein, triglycerides, urea, uric acid, angiotensin converting enzyme, BHBA, caffeine, FRAP, free fatty acids, fructosamine, glycerol, lactate lipase, vitamin C, urine alcohol, para amino benzoic acid
  • Beckman Coulter DU 640 Spectrophotometer:  carbonyls
  • Cholestech GDx:  hemoglobin A1C (point of care testing)
  • Cholestech LDx:  glucose, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides (point of care testing)
  • ELISA – P Lab or Bio Rad Plate Reader:  endothelin 1, IGF 1, IGF 2, IGF BP1, IGF BP3, Cortisol (saliva), DHEA (saliva), Progesterone (saliva), Testosterone (saliva), PAI-1, Blood contamination (saliva), ox40 ligand, crosslaps, tartrate resistant acid phosphatase, PTH related peptide, SCD40L, substance P, VCAM, e selectin, GLP-1, ICAM, gastric inhibitory peptide
  • Bio Rad HPLC:  dopamine, epinephrine, norepinephrine
  • Siemens 2000:  ACTH, cotinine, C peptide, C reactive protein (high sensitivity), cortisol, deoxypyridinoline, DHEAs, estradiol, ferritin, folate, free T3, free T4, FSH, growth hormone, homocysteine, insulin, LH, myoglobin, progesterone, prolactin, PSA, PTH, SHBG, troponin, T uptake, T3, T4, TSH, vitamin B12, thyroglobulin
  • Helena Laboratories Hematofluorometer:  Zinc protoporphyrin
  • IL ACL 8000:  factor VII, fibrinogen, prothrombin time
  • Lifescan Ultra One Touch:  glucose (point of care testing)
  • Luminex Labmap 100 :  apolipoprotein AII, apolipoprotein CIII, IL-1a, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-15, IL-17, G-CSF,  GM-CSF, IFN-g, MCP1, MIP-1a TNF-a, eotaxin, IP-10
  • Manual Procedures:  HCG (urine or blood), occult blood, urine color, urine appearance, urine drug screen (amphetamine, barbiturate, benzodiazepine, cocaine, ecstasy, methadone, methamphetamine, morphine, phencyclidine, propoxyphene, THC, tricyclic antidepressants)
  • Microscopic analyses (urine):  amorphous, bacteria, casts, crystals, epithelial cells, mucus, red blood cells, white blood cells.
  • Packard Riastar gamma counter (radioimmunoassay):  1,25 dihydroxy vitamin D, 17 hydroxy progesterone, 25 hydroxy vitamin D, adiponectin, aldosterone, androstenedione, angiotensin 1, bone specific alkaline phosphatase, DHEA, estrone sulfate, glucagon, leptin, melatonin, neuropeptide Y, osteocalcin, PINP, PYY, renin, resistin, reverse T3, testosterone (free and total), PINP, calcitonin, calcitonin gene related peptide, CCK, CRF, ghrelin                   
  • Varian AA Spectrophotometer:  cadmium, zinc, copper, selenium, arsenic
  • Perkin Elmer LS50B luminometer:  ORAC, enterostatin
  • Yellow Springs Instruments Glucose Analyzer:  glucose (point of care testing)

Data Management

The database management team’s primary responsibility is the implementation and maintenance of the Central Clinical Database, the institution's primary archive of clinical research data. In addition, our programmers are charged with development of the specialized applications that are used to collect clinical data from diverse sources throughout the institution. Also, this group has responsibility for the continuing development of Clinical Data Access (CDA), an internal application that provides authorized users a secure web-based portal to the clinical database.

Energy Expenditure

Eric Ravussin, PhD is the scientific director and Leanne Redman, Ph.D. oversees the quality control of the energy metabolic core.  The core laboratory consists of two Respiration Chambers (whole-room indirect calorimeters) for the assessment of 24 hour energy expenditure and substrate oxidation, and fourteen portable ventilated hood systems (8 MaxII, AEI Technologies, Naperville, IL; 6 Deltatrac Metabolic Monitors, Datex-Ohmeda, and 1 Vista-MX/REE unit, Vacuumed, Ventura CA) for the assessment of resting energy expenditure and substrate oxidation and thermic effect of food. The core is staffed with a biomedical engineer and a research specialist.

Food Intake

Pennington Biomedical Research Center specializes in the assessment of energy intake and has developed and validated methodology for use in free-living conditions and controlled laboratory settings.  We are able to assess subjective ratings of appetite using Visual Analogue Scales (VAS), which complement objective measures of food intake. VAS are commonly used to assess changes in appetite and satiety due to feeding paradigms, pharmaceutical compounds, or behavioral (lifestyle) interventions.  The Pennington Biomedical team also empirically evaluates the effect of behavioral (lifestyle) and pharmacological interventions on energy intake and energy expenditure.  Finally, the team specializes in free-living assessment of energy expenditure by using a variety of accelerometer devices and doubly labeled water (in conjunction with the Mass Spectrometry Core).   

The Food Intake lab includes three separate eating rooms that are each equipped with Universal Eating Monitors (Kissileff, Klingsberg, & Van Itallie, 1980). Universal Eating Monitors consist of a scale that is concealed in a table and connected to a computer that automatically records the weight of food removed (eaten) from a plate on top of the scale. Each table is covered with a tablecloth, and the participant is not acutely aware that food intake is being monitored. Universal Eating Monitors allow analyses of cumulative food intake throughout the course of the meal, and each of the eating rooms includes a desktop computer that participants use to rate their subjective levels of appetite with VAS. The Laboratory also includes a monitoring room that houses desktop computers and closed-circuit video equipment to record food intake behavior in the adjacent eating rooms. Lastly, the laboratory includes a taste testing area and prep area, which allows food intake to be quantified by weighing food before and after participants’ meals.

Imaging

The Imaging Core is under the direction and supervision of Kori Murray, MS. The Core is designed to provide anatomic imaging and in-situ biochemistry/metabolism for clinical research.  Imaging Core body composition instrumentation includes the following:  two DXA instruments (GE Lunar iDXA and Hologic Discovery), an ECHO MRI [ultra-low field strength NMR] instrument, and BodPod and PeaPod systems by Cosmed.  Additional Core instrumentation includes an Itamar EndoPAT 2000 for endothelial function assessment, a Toshiba Aplio SSA-770 ultrasound system for echocardiography and other ultrasound studies, and a Horiba Jobin Yvon optical system that is designed to measure skeletal muscle oxygen consumption rates.  Researchers also have access to a 64-slice CT scanner at the Baton Rouge General – Bluebonnet campus. The Core instrumentation also includes a GE Signa Excite 3.0T HDxT magnet with full multinuclear spectroscopy and functional capabilities. The lab is equipped with a spectrum of coils (multichannel head, split head, multichannel body, knee, proton GP flex, and 4cm, 6cm, and 8 cm singly and doubly tuned 31P transmit/receive).  A GE 3.0T 750 wide bore magnet (with full multinuclear spectroscopy and imaging capabilities) and a Proteus XR radiographic system will be installed in early 2013. The Core is staffed with trained and licensed medical specialists, radiology technologists, and image/data analysts.

Inpatient Unit

Led by William Cefalu, M.D., our Inpatient Unit has the ability to conduct traditional phase I studies.  Additionally, we can explore the physiology and safety of new compounds to give greater insights into mechanisms and efficacy.  Examples include the collection and processing of fat and muscle biopsies that can be analyzed via cell sizing, electron microscopy, cell culture, mRNA array studies, genetic studies, metabolomics, immunohistochemistry, fluorescent imaging studies and protein expression analysis.  Even during a phase I drug study that looks at safety; the Inpatient Unit can evaluate metabolic rate and fat oxidation using hood or chamber technology. Insulin sensitivity can be evaluated with euglycemic hyperinsulinemic clamp studies or with the frequently sampled IV Insulin-Glucose Tolerance Test.  Additional testing in the Inpatient Unit includes but is not limited to: oral glucose tolerance testing, meal tolerance testing, feeding studies, pharmacokinetic testing, and accommodating overnight and extended stays. The unit is staffed with ACLS Certified Nurse Practitioners, Registered Nurses, and Licensed Practical Nurses. The unit is open seven days a week, twenty-four hours a day, including most holidays.

Integrated Biology Core

In vivo evaluation of bioactive constituents is one of the primary research projects in the Botanical Laboratory led by Dr. William Cefalu.  The goal of the laboratory is to study the cellular mechanisms operative in insulin-sensitive tissue that contribute to the development of insulin resistance on a whole body level in humans. The lab has been evaluating dietary alterations of trace minerals and the effect on phytochemicals.

Internal IRB

Pennington Biomedical Research Center Human Research Protections Program (HRPP) exists to promote high quality, ethical research.  HRPP does this by serving as the advocate for the rights and welfare of persons who participate in research programs conducted by the Pennington Biomedical researchers.  The Human Research Protections Program office assists researchers in complying with federal, state and institution policies regarding experimentation involving human subjects and oversees the review and conduct of research conducted by federally registered Institutional Review Boards (IRB’s).

In Vivo Evaluation of Bioactive Constituents

In vivo evaluation of bioactive constituents is one of the primary research projects in the Botanical Laboratory led by Dr. William Cefalu.  The goal of the laboratory is to study the cellular mechanisms operative in insulin-sensitive tissue that contribute to the development of insulin resistance on a whole body level in humans. The lab has been evaluating dietary alterations of trace minerals and the effect on phytochemicals.

Mass Spectrometry

The Mass Spectrometry Core is directed by Jennifer Rood, Ph.D., DABCC, FACB and is divided into two sections:  Energy Expenditure/Body Composition and Metabolism.

The Energy Expenditure/Body Composition section focuses on the measurement of energy expenditure using the doubly labeled water technique.  Additionally, measurements of total body water are performed using either deuterium or oxygen 18.  This section has four Finnigan isotope ratio mass spectrometers (a Delta S, a Delta XP, and two MAT 252s).  The laboratory also has automated sample preparation devices interfaced to the mass spectrometers.  Two gas benches are used for 18O sample preparation and three H devices are used for the sample preparation of deuterium (2H).  With these instruments, we can accurately and precisely measure the amount of heavy isotopes, such as 18O and deuterium, in relation to the common isotopes, 16O and 1H, for the measurement of energy expenditure in studies of obesity.  The instruments are also used to measure 18O and deuterium as measures of total body water.  The Delta XP is also used for analysis of 13C in breath samples as a marker of gastric motility.

The Metabolism section focuses on the measurement of stable isotopes that are used to examine lipid, protein, and carbohydrate metabolism.  This section has three gas chromatograph/mass spectrometers (Agilent 6890 GC/5975 MS, Agilent 6890 GC/ 5975b MS and an Agilent 7890GC/5975c MS).  All three mass spectrometers have EI and CI capabilities, and positive or negative ion monitoring, for measurement of any stable isotope labeled (e.g. 2H, 15N, 13C) organic compound.  This equipment is used to examine cholesterol metabolism in studies of cardiovascular disease, and glucose, amino acid and fatty acid metabolism in studies of obesity and diabetes.

Outpatient Clinic

The Outpatient Clinic at Pennington Biomedical is responsible for the oversight and coordination of all clinical trials performed. Specifically, the Outpatient Clinic offers a broad array of services including: screening of potential study participants, completion of protocol specific clinic visits, regulatory oversight for all studies, study-specific study coordinators and back-up coordinators, dispensing of study medications, completion of case report forms and quality assurance of source documentation. The Clinic is comprised of general examination rooms, interview rooms, phlebotomy area, pharmacy, and specialized assessment rooms.

The Outpatient Clinic has the ability to evaluate food intake and body composition in addition to doing the standard blood, urine and EKG testing that typifies the usual early phase pharmaceutical development trials. Even with phase 1 single dose studies, a person can come in one day and take a dose of a candidate drug that is postulated to treat obesity and have the usual pharmacokinetic and safety blood draws while also being given a lunch meal to eat as much or as little of as makes them feel satisfied after fasting from dinner the night before. On another day, the same person can take a placebo and repeat the same study. The difference in food intake can be a predictor of weight loss that will be seen with the drug. This gives the added value to the company of a hint about the efficacy of their drug during the single dose testing of a phase 1 trial. In addition to food intake, the clinic has a vascular ultrasound technician that can evaluate heart valves, endothelial function by brachial artery dilatation or finger plethysmography and measure carotid arterial thickness as a measure of atherosclerosis in addition to the ultrasound imaging that is available in other places. In multiple dose studies, the Outpatient Clinic has the capability to perform body composition using DEXA, integrate visceral fat area using CT scanning, and evaluate body fat without using any radiation. An echo-MRI device allows fat measurements in children and pregnant women that cannot be exposed to radiation. Thus, the Outpatient Clinic gives additional value in all phases of pharmaceutical development from single dose safety studies to large phase three studies looking at efficacy and safety.

Proteomics/Metabolomics

The Proteomics and Metabolomics Core is directed by Jennifer Rood, Ph.D., DABCC, FACB and is staffed with a lab manager, research specialist, and a post-doctoral student.  The facility has resources to perform both proteomics and metabolomics experiments from a variety of samples such as cells, sub-cellular fractions, secreted media, tissues and biological fluids.

The facility is equipped for both two-dimensional gel electrophoresis as well as two-dimensional liquid chromatography separations of proteins and peptides followed by mass spectrometric analysis and database searching. 

Recruiting

We have a team dedicated to recruitment services for our clinical trials.  The Recruitment Core manages all related activities, from marketing and advertising to screening all potential participants to determine study eligibility.  Driven by advanced technology, traditional and social media, as well as grassroots marketing, incoming inquiries are directed to a call center that is operated by 4 full-time recruiters and is equipped with a Uniform Call Distributor (UCD) system. A UCD system expands the capability of a traditional phone system and allows multiple individuals to call simultaneously and be directed to the next available recruiter. Our recruitment effort utilizes an electronic message tracking application that tracks the outgoing phone call activity and a “smart” electronic phone system that screens potential participants upon initial phone contact and seamlessly matches them to alternative studies when deemed ineligible for the original study inquiry.

Sleep Testing

The Pennington Biomedical Research Center Sleep Lab is under the direction of Weihong Pan, MD, Ph.D. The laboratory serves in two main capacities: The two-bed sleep lab performs diagnostic and titration polysomnography and multiple sleep latency and the Sleep Clinic provides outpatient clinic consultation on any type of sleep disorders, including insomnia, hypersomnolence, sleep related movement disorders, sleep related eating disorders, circadian rhythm sleep disorders, shift worker disorders, sleep apnea, and other sleep disordered breathing related to heart, lung, GI, and neurological problems. The lab utilizes Dr. Pan's expertise and the services of a part-time sleep technician.