Clinical Research and Pharmacology Core (CRPC)

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This Core, led by Elena Volpi, MD, PhD, FGSA and Dean Kellogg, MD, PhD, assists basic and clinical investigators in developing rigorous and appropriately powered clinical studies and trial concepts that will lead to innovative approaches to improve healthspan and lifespan, and facilitates implementation and execution of translational human studies and clinical trials by investigators.

The Core provides expertise and coordinated access to resources and technology in both the San Antonio OAIC and facilities throughout our institution to maximize the depth of phenotypic characterization relevant to aging in trial outcomes. Training in writing papers for clinical research for early-stage faculty and those new to clinical research is also available. This Core is also available to provide research project consultation and planning, assistance with safety and regulatory compliance processes, facilitates research subject recruitment and retention, and coordinates relationships with relevant San Antonio OAIC Cores and other Core facilities of our institution.

This core can also perform pharmacokinetic studies in humans. PK parameters of parent drugs and metabolites can be analyzed in order to understand the pharmacotherapeutics of potential new treatments.

ACCOMPLISHMENTS

With our support, investigators have made major advances and novel discoveries in clinical translational geroscience, including:

• The first clinical trial of rapamycin in healthy older adults (Kraig, E., Linehan, L. A., Liang, H., Romo, T. Q., Liu, Q., Wu, Y., … & Chiodo, L. (2018). A randomized control trial to establish the feasibility and safety of rapamycin treatment in an older human cohort: Immunological, physical performance, and cognitive effects. Experimental gerontology, 105, 53-69.)
• The first clinical trial of senolytics in humans, in partnership with Mayo Clinic and Wake Forest University (Justice, J. N., Nambiar, A. M., Tchkonia, T., LeBrasseur, N. K., Pascual, R., Hashmi, S. K., … & Kirkland, J. L. (2019). Senolytics in idiopathic pulmonary fibrosis: results from a first-in-human, open-label, pilot study. EBioMedicine, 40, 554-563.)
• With initial pilot funding, the launching of a randomized-controlled trial of metformin for frailty prevention in older adults (Espinoza, S. E., Musi, N., Wang, C. P., Michalek, J., Orsak, B., Romo, T., … & Li, Y. (2020). Rationale and Study Design of a Randomized Clinical Trial of Metformin to Prevent Frailty in Older Adults With Prediabetes. The Journals of Gerontology: Series A, 75(1), 102-109.)
• Initiation of a data registry and specimen repository, the South Texas Aging Registry and Repository (see below)

THE SOUTH TEXAS AGING REGISTRY AND REPOSITORY (STARR)

The South Texas Aging Registry and Repository (STARR) is a database and specimen resource of adult subjects from the South Texas community. De-identified repository data and samples are available to qualified investigators for future studies related to aging. Or, investigators may contribute de-identified specimens and data to the repository.

SA OAIC STANDARD BATTERY OF TESTS

The following tests should be considered for inclusion in SA OAIC clinical studies. Use of tests from this “standard battery” will facilitate comparisons among different OAIC studies. Depending on the study, some or all of the battery may be incorporated. Documents referenced are provided at the right sidebar of this page.

GENERAL EVALUATION:

• Anthropometry (Height, Body Mass, Abdominal Circumference)
• Activities of Daily Living and Instrumental Activities of Daily Living assessments (See GRAF-The Lawton Instrumental Activities of Daily Living Scale)
• Veterans VR-36 Health Status Questionnaire (See VR-36 form and How to score VR-36; KAZIS-The Veterans SF-36 Health Status Questionnaire; BRAZIER-Validating the SF-36 health survey questionnaire-new outcome measure for primary care)

PHYSICAL PERFORMANCE EVALUATION

• Hand Grip strength (See GRIP STRENGTH instructions + score sheet; TAEKEMA-Handgrip strength as a predictor of functional, psychological and social health)
• Isokinetic strength with Biodex
• Gait Speed (10-foot, 15-foot, 4-meter, 40-feet) or 6 Minute Walk Test (See GAIT SPEED instructions + score sheet; 6 Minute Walk Test Instructions + Score Sheet; ATS Statement- Guidelines for the Six-Minute Walk Test)
• Short Physical Performance Battery (SPPB-three tests of physical function: habitual walking speed; time to rise from a chair and sit down five times (chair stands; and standing balance) (See Short Physical Performance Battery Protocol and Score Sheet)
• Minnesota Leisure Time Activity Questionnaire (MLTA-An interviewer-administered questionnaire to evaluate energy expenditure in leisure time physical activity) (TAYLOR-A questionnaire for the assessment of leisure time physical activities
• Frailty assessment (Fried phenotype and deficit accumulation)
• VO2 peak (treadmill, cycle)

ACTIVITY & SLEEP

• Actigraph activity and sleep monitoring (Actigraph, LLC)

NUTRITION

• ASA24, myfitnesspal, Diet History Questionnaire, Three Factor Eating Questionnaire

METABOLISM

• Oral glucose tolerance testing
• Meal tolerance testing
• Insulin clamping
• Indirect calorimetry
• Body composition DXA
• Bone DXA

COGNITIVE EVALUATION

• SLUMS or MoCA-global cognitive assessment (See SLUMS and MoCA forms; BUCKINGHAM-Comparing the cognitive screening tools-MMSE and SLUMS)
• EXIT25 or CLOX 1 and II-Executive function (See EXIT25 instructions and EXIT25-Executive Interview 25 form; CLOX test form; ROYALL-Clock drawing is sensitive to executive control-a comparison of six methods)
• Texas Assessment of Processing Speed (TAPS)-uses sorting and categorization as test of Executive function; has alternative forms to minimize learning effects with repeated administration (See TAPS instructions, A+B forms, and A+B scoring sheets)
• Geriatric Depression Scale-depression screen (See GDS-Short Form; GREENBERG-The geriatric depression scale (GDS))
• Centers for Epidemiologic Studies Depression Scale (CES-D)

CONSTIPATION EVALUATION

• PAC-SYM score (See PAC-SYM form; NERI-Confirmatory factor analysis of the patient assessment of constipation-symptoms (PAC-SYM) among patients with chronic constipation)

MICROVASCULAR FUNCTION

• Laser-Doppler Flowmetry with Local Heating-NO dependent vasodilation (noninvasive) (See CHOI-New approach to measure cutaneous microvascular function- an improved test of NO-mediated vasodilation by thermal hyperemia)

CARDIOVASCULAR EVALUATION

• Aortic Pulse Wave Velocity-compliance assessment (noninvasive) (See BOUTOUYRIE-Assessment of pulse wave velocity)
• Resting EKG and continuous EKG monitoring during exercise

CLINICAL LABS & BIOSPECIMENS

• CBC, chemistry, HbA1c, coagulation, urinalysis
• Collection of blood, skeletal muscle, skin, adipose, and cerebrospinal fluid

IMMUNOLOGY & SINGLE CELL ANALYSIS

• Flow cytometry, humoral responses, T cell function
• Preparation of samples for genetic sequencing